Localized fat removal and cellulite

Source date: 2026-11-09. Recorded in this review: November 10, 2026. Evidence: Historical Phase 2 program; November registry update, no results.

Johns Hopkins' NCT03150511 is a historical new-indication program, first registered May 12, 2017 and started in June 2018. It plans 36 people after repaired ulnar nerve injury, randomized to tesamorelin or no treatment. The primary endpoint is pinch strength at 12 months, with nerve conduction, sensation and hand-function measures secondary.

The November 9 registry update still lists recruitment and estimates primary/final completion in December 2027; no results are posted. Masking remains unresolved: narrative text says assessors/statisticians are blinded, whereas the structured field says quadruple masking despite an untreated comparator. Do not present this as a securely participant-blinded trial.

This belongs here because the watch includes tesamorelin's investigational indications. It is not a new November launch and provides no visceral-fat or regional-fat-removal outcome, nor evidence of approved nerve regeneration or generalized muscle benefit. The established HIV-associated abdominal-fat indication does not confer approval for nerve injury.

Next: Actual completion and functional outcomes; December 2027 is a registry estimate, not a publication commitment.

Sources: ClinicalTrials.gov · NCT03150511.

Coverage and remaining gaps: Focused/incomplete review; do not advance the full successful-check timestamp. Named CT.gov records and bounded discovery/paper searches were retrieved, but this is not complete worldwide registry, regulator, conference, device/procedure, safety or audio coverage. Retrieval continued after the scheduled 9 a.m. heartbeat; source dates are preserved. Twenty-one named records, 24 recent registry records and six paper-search records retrieved; the broader registry query timed out. Existing CBL-514 SUPREME sponsor/registry recruitment discrepancies, RZL-012 China filing forecast and small cellulite datasets remain unresolved or already recorded. No new selected fat-removal efficacy result. Tesamorelin nerve recovery is a recovered historical indication lead, not a new fat result; the TRIUMPH frailty study remains separate. Complete international registry, metabolic outcomes and device/procedure appraisal remain gaps.

Informal-source coverage: Searched indexed CBL-514/RZL-012/tesamorelin Reddit and podcast/talk leads. Confounded before/after anecdotes and unverified supply claims provide no new formal efficacy or access evidence. Podcast descriptions were not full recordings; no selected new specific rumor.

Full coverage record.

Source date: 2026-11-06. Recorded in this review: November 6, 2026.

Caliway’s November 6 announcement says China’s CDE/NMPA has authorized CBL-0102 to proceed. This is a randomized, open-label, single-dose, parallel-group study of approximately 30 healthy participants at two Chinese sites, assessing ethnic sensitivity in pharmacokinetics, safety and tolerability across dose levels.

Enrollment is forecast for December 2026; completion is planned for Q2 2027, with data shortly afterward. These are sponsor forecasts, not verified recruitment, dosing or completed results. Numerical doses, a matched original registry and the regulator’s authorization document were not independently retrieved.

CBL-0102 is separate from SUPREME-01/02 and does not supply pivotal fat-reduction efficacy, new visceral-fat results or marketing approval. CBL-514 remains investigational; this announcement establishes no U.S. approval or routine availability.

Sources: CBL-514 gains sponsor-reported China trial clearance.

Coverage and remaining gaps: focused_incomplete; Focused/incomplete: retrieved records and selective appraisal do not equal complete worldwide trial, paper, regulator, device/procedure, safety or informal-source coverage. Preserve full successful-check timestamps and baseline flags.; CBL-0102 exact doses, matched Chinese primary registry, independent CDE letter and actual enrollment/first dose were not recovered. SUPREME-02 remains not-yet-recruiting in the original Oct20 registry despite Oct29 sponsor enrollment announcement. The sponsor specifies U.S./Canada sites, while registry also lists Australia; active accepting sites cannot be inferred. No new SUPREME Phase 3 efficacy or RZL-012/tesamorelin new-indication result verified.

Informal-source coverage: Original indexed CBL-514/tesamorelin/cellulite searches sampled. Seller/self-experiment reports excluded; no distinct new attributable development rumor selected. November 15 ObesityWeek combination poster is explicitly preclinical.

Full coverage record.

Source date: 2026-11-02. Recorded in this review: November 3, 2026.

First posted November 2, NCT07908953 plans 150 adults receiving indication-specific pbserum Plus recombinant collagenase/lipase/hyaluronidase protocols, with pbserum HA 2.0 when applicable. It is an open-label, single-group umbrella study covering localized adiposity, cellulite, laxity, fibrosis/nodules and pathological scars. Fat thickness, treated-area volume, cellulite scores, skin mechanics and adverse events are separate measures.

There are no results or untreated/comparator groups. Changes cannot establish selective fat removal, durable dimpling improvement or regeneration. The record has inconsistent 90-versus-180-day fat-thickness wording and primary completion December 31, 2026 despite estimated November 1 start and 180-day outcomes. It still says not yet recruiting after that estimated start. Product dose/subprotocol and regulatory identity need further verification; registration does not establish U.S. approval or routine availability.

U.S. status: No new U.S. authorization follows from this study or registration.

Next milestones: pbserum umbrella primary completion: 2026-12-31 (Registry estimate; inconsistent with follow-up windows); pbserum umbrella final completion: 2027-07-30 (Registry estimate).

Sources: ClinicalTrials.gov · NCT07908953.

Coverage and remaining gaps: focused_incomplete; do not advance full successful-check timestamp. Complete retrieval for these bounded queries is not complete worldwide clinical appraisal. Full international registry, conference, device/procedure, detailed safety and audio coverage remains incomplete.; SUPREME-02 NCT07526974 still last posted October 20 and not yet recruiting despite October 29 sponsor announcement. Exact actual first-dose day, sites actively accepting participants and numerical Phase 3 results remain unverified.; Recombinant-enzyme umbrella has no control and conflicts between enrollment/start, primary-completion and 90/180-day outcome windows. Full long-term cellulite dimpling and fat-depot safety appraisal remains incomplete.

Informal-source coverage: Sampled original Reddit and indexed podcast/talk leads. CBL-514 gray-market self-experiment and seller claims were excluded; October 3 Hunter Williams indexed discussion is general, older and not a new formal-study event. No new selected development rumor; full original audio unreviewed.

Full coverage record.

Source date: 2026-10-29. Recorded in this review: October 30, 2026.

Caliway announced enrollment initiation in SUPREME-02 (CBL-0302/NCT07526974), its second placebo-controlled Phase 3 trial of abdominal subcutaneous-fat reduction. About 320 participants and 30–35 sites across the United States, Canada and Australia are planned. This is a recruitment milestone, not efficacy or safety results; the exact first enrollment and dosing dates were not disclosed.

The original registry remains not yet recruiting, last updated October 20, with an estimated October 2026 start. Preserve this lag rather than silently overriding either source. It describes up to four CBL-514 or saline treatments four weeks apart, up to 120 mL per treatment; a patient-reported abdominal-fat response plus clinically meaningful MRI reduction is primary in that record. The sponsor also describes clinician assessments and imaging, without a numerical result.

August 2027 primary and October 2027 final completion are registry estimates, not guaranteed readouts. SUPREME-01 remains a separate ongoing pivotal study. Combination findings advertised for November ObesityWeek are explicitly preclinical, not new human evidence against weight regain or visceral fat.

U.S. status: Investigational; trial enrollment is distinct from U.S. approval or routine availability.

Next milestones: SUPREME-02 primary completion: 2027-08 (Registry estimate; month precision, not promised results); SUPREME-02 final completion: 2027-10 (Registry estimate; month precision).

Sources: SUPREME-02 enrollment announcement; SUPREME-02 original registry; SUPREME-01 / CBL-0301 (NCT07140939).

Source date: 2026-10-30. Recorded in this review: October 30, 2026.

Caliway's October 30 clarification states that CBL-514 has no marketing approval in any country or jurisdiction, is not commercially available in any market, and has no authorized third-party supplier, distributor or seller. The company issued the statement after identifying online sales and affiliation claims.

This is a new primary clarification of access, not a new safety-event count, trial suspension or efficacy result. Online products advertised using the compound's name cannot be assumed to match the investigational formulation, and their appearance does not establish regulatory approval or authorized access. SUPREME trial participation remains a separate research setting.

U.S. status: Sponsor states no marketing approval or commercial availability anywhere, including the United States.

Sources: Unauthorized online sales clarification.

Source date: 2026-07-08. Recorded in this review: October 30, 2026.

Baseline added October 30, not new clinical news. The July 8, 2026 TRIUMPH protocol (NCT06554717) plans 100 sedentary adults aged 50–80 with HIV, prefrailty/frailty and excess abdominal adiposity. Participants receive tesamorelin WR 1.28 mg daily or identical placebo for 24 weeks, both with semisupervised home exercise, followed by 24 weeks off drug while independent exercise is encouraged.

The primary endpoint is change in time for ten repeated chair stands at week 24. Leg-press strength, walking performance, DXA appendicular lean tissue, CT muscle size/density and visceral-fat area are separate outcomes. This directly tests function rather than assuming more lean tissue means better strength. The protocol monitors IGF-1 and metabolic safety; no efficacy or safety results are posted.

The registry still lists recruiting, an actual July 10, 2025 start and May 19, 2026 last update. June 16, 2028 primary and December 1, 2028 final completion are estimates. Existing HIV-associated abdominal-fat use does not establish a general-population visceral-fat, frailty or muscle-function indication.

U.S. status: Existing HIV-associated abdominal-adiposity use is distinct from approval for frailty, muscle function or general-population fat reduction.

Next milestones: TRIUMPH primary completion: 2028-06-16 (Registry estimate; not public-results commitment); TRIUMPH final completion: 2028-12-01 (Registry estimate).

Sources: primary source; PubMed Central · PMC13347827; DOI · 10.1136/bmjopen-2026-120740.

Coverage and remaining gaps: focused_incomplete; do not advance full successful-check timestamp. Focused incomplete appraisal only; complete retrieval for these bounded queries is not complete worldwide clinical review. Full successful-check timestamps remain unchanged. Independent national registries, every conference appendix, all device/procedure safety and all podcast audio/comments remain incomplete.; SUPREME-02 actual first-enrollment/dose day and registry reconciliation remain unverified.; No new matched RZL012 efficacy/China filing or tesamorelin new-indication result verified; all devices/cellulite comparative evidence not appraised. New 30-woman PLLA/CaHA cellulite registry NCT07908069 describes a study completed2025 with no results; do not call it a newly started2026 trial.

Informal-source coverage: Targeted original Reddit and indexed talk/podcast searches sampled; an anonymous October24 tesamorelin reaction account has unverified product identity, self-experimental co-exposures and no adjudicated causality. It does not establish a new formal-trial safety signal. No selected new development rumor; marketplace sourcing claims remain separate from authorized access.

Full coverage record.

Source date: 2026-10-21. Recorded in this review: October 27, 2026.

New disclosure, older study. Results for CBL-0201EFP Stage 1 (NCT05632926), conducted January–May 2023, were first posted October 21, 2026. Twelve women received one course of 40, 60 or 80 mg CBL-514, four per dose; 11 completed. There was no placebo or randomization.

At week 4, mean change in the 0–9 modified Hexsel cellulite score was −2.0 (SD 0.9), −1.5 (0.9) and −2.6 (1.5), respectively. The analysis uses eight thighs per dose, nested within four participants, not eight independent people. Counts improving at least one severity category were 5/8, 7/8 and 7/8 thighs; despite the endpoint title mentioning percentages, the posted values are counts.

Non-serious adverse events affected 3/4, 3/4 and 2/4 participants, mainly injection-site reactions. No serious events or deaths were reported during four-week follow-up. These tiny uncontrolled groups cannot establish comparative efficacy or long-term safety. Cellulite dimpling/texture is distinct from fat-volume, visceral-fat or weight reduction; these are not SUPREME Phase 3 abdominal-fat results.

U.S. status: Investigational for cellulite; no U.S. approval established.

Next milestones: Larger controlled cellulite evidence and durability: date unknown (Unknown; no verified disclosure date).

Sources: ClinicalTrials.gov · NCT05632926; ClinicalTrials.gov · NCT05632926.

Coverage and remaining gaps: focused_incomplete; do not advance full successful-check timestamp. Worldwide completion is not established: CTIS, ChiCTR/jRCT and other national registries, every indexed article, every conference poster and unindexed social/audio sources were not exhaustively appraised. Keep the full successful-check timestamp unchanged.; No exhaustive independent review of all localized/visceral-fat interventions, lipedema devices or all cellulite procedures. No new randomized tesamorelin indication result verified.; SUPREME-01 recruiting and elapsed forecasts do not establish completed enrollment. Repeated stock stories misstate responder percentages as fat-volume loss and are not independent results.

Informal-source coverage: scope: Targeted original Reddit and indexed podcast/talk searches for CBL-514, RZL-012, tesamorelin and fat/cellulite programs. Sponsor index and dated release checks.; status: No selected new development rumor; self-sourcing/compounding anecdotes excluded. Reposted sponsor percentages are not independent confirmation.; limitations: Not a complete Reddit-comment or podcast-audio census.

Full coverage record.

Source date: October 7, 2026 first registry posting. Evidence: registered human pilot; no results.

SCULPT/NCT07862920, led by Frank Greenway at Pennington Biomedical, plans 10 women aged 18–50 with BMI 25–35 and self-reported thigh cellulite. Each participant will apply active naringenin/beta-carotene/menthol cream to one thigh and placebo to the other for eight weeks, with randomized side assignment and participant/provider/investigator masking. The primary endpoint is the between-thigh difference in girth. Photographic smoothness and microdialysis lipolysis are described in the narrative, but not fully specified as structured outcomes. This is a within-person design despite a structured “parallel” label.

Limitations and safety: Ten participants and circumference do not establish selective adipose-volume loss, cellulite-dimpling improvement, durability, or general safety. No results are posted. The record does not establish a new U.S. therapeutic authorization or efficacy of retail formulations. Next: actual start; January 15, 2027 start and July 15, 2027 primary/final completion are registry estimates, not publication commitments.

Original registry.

Remaining gaps: Read the current assigned topic and canonical scope/state. Named original registry records refreshed; all pages of broad ClinicalTrials.gov discovery for September 5–October 9 were retrieved (205 records, with incidental matches excluded). This honors the seven-day overlap from the saved September 12 full successful check.; Europe PMC original-literature discovery again returned HTTP 503. Targeted primary publisher, sponsor and conference searches were performed, but the worldwide paper/regulator/procedure and original-audio census remains incomplete. Preserve last_successful_check_utc.; SUPREME-01 remains recruiting 320, last posted September 22; CBL-0206 records, AYP-101 completed/no results, tesamorelin and RZL-012 records retain saved status. Caliway index still ends with October 2 EASD report. No new SUPREME-02, China NDA filing or broader tesamorelin indication verified.; A newly posted Assiut 40-person double-chin cohort NCT07864246 is not yet recruiting and has only one broadly described group; no randomized modality comparison or result. Not promoted as efficacy. Full original CBL-514 EASD tables, cellulite comparative census and regulator/rare-harm review remain gaps.

Informal-source coverage: October 7 BodyHackGuide thread https://www.reddit.com/r/BodyHackGuide/comments/1wzmfif/down_30_on_rt_what_else_to_add/ and October 9 tesamorelin/blend discussion are self-experimentation, not formal-program outcomes or attributable development forecasts. Existing CBL-514 sourcing threads were deduplicated. No new rumor selected; full investor/podcast recordings incomplete.

Full coverage record.

Source/event date: 2026-10-02. Evidence: EASD conference report reproduced by sponsor; exploratory human subgroup.

Caliway posted the EASD press-room report on October 2 after the September 30 presentation. A pooled MRI subgroup from CBL-0204/0205 included 41 people at baseline (23 CBL-514, 18 placebo) and 40 with late follow-up (23, 17). At four weeks after final treatment, visceral-fat volume changed −12.01% versus +5.68%; at the pooled 8–12-week follow-up, −10.45% versus +11.76%. The latter is a 22.21-percentage-point difference, not 22.21% absolute fat loss.

These selected, small, short-term data do not establish sustained metabolic or cardiovascular benefit. Follow-up timing differs between the two pooled trials; confidence intervals and full missing-data methods were unavailable. The report describes mainly temporary injection-site reactions and no serious adverse events, without a detailed subgroup safety table. Claims about limiting weight regain after stopping tirzepatide remain animal evidence. CBL-514 is investigational. SUPREME-01 recruitment continues; end-2027 pivotal results are an expectation in this report, separate from registry-estimated July 2027 primary completion.

Next milestone: SUPREME-01 primary completion July 2027 registry estimate; pivotal results end-2027 conference forecast.

Caliway EASD human visceral-fat subgroup report; SUPREME-01 / CBL-0301 (NCT07140939).

Source date: 2026-09-23. Event date: exact date not disclosed. Date basis: announcement. Evidence: sponsor development announcement; registry cross-check.

Caliway reports that its pivotal abdominal-fat study has entered treatment, beyond the earlier recruitment announcement. SUPREME-01/CBL-0301, NCT07140939, plans 320 participants in the U.S. and Canada in a blinded randomized placebo comparison. The sponsor reports first dosing and continuing recruitment. The September 22 registry remains recruiting, with actual study start September 1 and estimated primary/final completion July/September 2027.

Limitations: September 23 is the announcement date; the exact first-dose day is undisclosed. Treatment initiation supplies no Phase 3 efficacy result. Two-grade patient/clinician improvement is assessed separately from MRI fat-volume change. The same release’s new semaglutide/eloralintide combination findings are preclinical, not human weight-regain evidence.

Safety: No new Phase 3 safety results.

U.S. status: Investigational; recruitment does not establish routine U.S. availability.

Next milestone: September 30 EASD presentation remains upcoming; July 2027 primary completion is a registry estimate, not a promised release.

Caliway first-dose announcement; SUPREME-01 registry.

Source date: 2026-09-24. Event date: 2026-09-24. Evidence: peer-reviewed randomized human study; primary abstract appraised.

A small comparison found no significant between-group advantage of shockwave treatment over complex decongestive therapy for lipedema. Thirty-three patients, 11 per group, received six sessions of shockwave therapy, complex decongestive therapy, or both. Assessment two weeks after treatment covered DXA fat mass, leg volume, pain and quality of life. Fat-mass changes were small and did not significantly differ between groups. Leg volume, pain and quality-of-life improvements also did not significantly differ between groups.

Limitations: Small sample, short follow-up and no untreated/sham group. Within-group improvement is not evidence of superiority or equivalence. The abstract provides no effect sizes or confidence intervals. Lipedema symptom/volume management must remain distinct from cosmetic fat removal, cellulite smoothing and durable fat-cell reduction.

Safety: The authors describe the approaches as safe, but the available abstract provides no adverse-event counts.

U.S. status: No new U.S. authorization or lipedema indication established.

Next milestone: Full numerical results, safety tables, registration and longer controlled follow-up remain undated.

Original PubMed abstract; Original DOI.

Source date: 2026-09-21. Event date: 2026-09-21. Evidence: Sponsor topline announcement.

Caliway's small placebo-controlled trial met its primary pain endpoint; the previously forecast September readout has occurred. CBL-0202DD/NCT06303570, randomized single-blind trial, registry n=19. Full-analysis-set pain change at week 20: −3.1 versus −1.9 points on a 0–10 scale, p=0.005. Week 24: −4.1 versus −1.7, p<0.0001.

Limitations: Sponsor-only, small sample, no CIs or arm denominators recovered. Dercum's painful lipomas are distinct from cosmetic abdominal fat, visceral fat or cellulite. Separate full-analysis and per-protocol estimates.

Safety: No drug-related serious AEs reported; mostly mild/moderate injection-site reactions, without arm-level counts.

U.S. status: Investigational for this use; no new U.S. approval.

Next milestone: Larger-trial timing unknown. Sponsor will assess lipedema-study feasibility; this is not a confirmed trial start. Separate visceral-fat presentation remains September 30.

Caliway September 21 Dercum readout; NCT06303570 registry.

Source date: 2026-09-22. Event date: 2026-09-01. Evidence: Trial-registry update.

The current record resolves the old not-yet-recruiting discrepancy for CBL-514's pivotal abdominal-fat trial. NCT07140939 posted September 22: RECRUITING; actual start September 1, 2026; planned enrollment 320. Primary completion July 2027 and overall completion September 2027, both estimates with month precision. Primary response requires ≥2-grade improvement on both patient and clinician abdominal-fat scales; MRI fat-volume change is secondary.

Limitations: Registry status is not a result. Earlier sponsor initiation announcement was August 31; retain both dates with their source meanings. Prior 300/May 2027 record is superseded.

Safety: No results posted.

U.S. status: Investigational; trial recruitment does not establish availability outside a trial.

Next milestone: Primary completion July 2027 (registry estimate); topline date not independently established.

NCT07140939 registry.

Source date: 2026-09-03. Evidence: Historical evidence recovered.

Linear Z adds a formal human device study for lower-abdomen and flank contouring. NCT07802431 was first posted on September 3 and is listed as recruiting. It plans to enroll 30 participants in a single-group, open-label study. Its primary endpoint is circumference change at day 90.

Limitations: No sham comparator, no results, circumference is not equivalent to measured fat volume or cellulite improvement. September 1 start remains estimated, not confirmed first enrollment.

Safety: Safety data pending.

U.S. status: This registration does not establish a U.S. clearance or approval.

Next milestone: Registry estimates primary completion December 20 and overall completion December 31, 2026; no release date.

NCT07802431 current primary registry.

• Source event date: August 31, 2026.
• Evidence type: sponsor development update.
• What changed: Caliway reports that pivotal Phase 3 SUPREME-01 (CBL-0301) began enrollment in the U.S. and Canada. It also reports FDA IND clearance for a Phase 2 combination study of CBL-514 and tirzepatide.
• Interpretation: These are development milestones. IND clearance permits a trial to proceed; it is not marketing approval. The source's weight-regain claims for the combination include animal evidence and do not establish human benefit.
• Next check: verify registry status and trial design, additional SUPREME studies, planned readouts, and the combination trial's registration and enrollment. Reconcile estimated registry dates with newer dated sponsor reports.
• Primary source: Caliway, August 31, 2026.
• Registry anchor: SUPREME-01 / NCT07140939.
• Publication anchor for baseline review: Phase 2b paper / PMID 42159040. Review the actual analysis population and missing-data handling before quoting efficacy percentages.

These program anchors are supplemented by the evidence review below.

Current assessment. CBL-514 has placebo-controlled human evidence for reducing local abdominal subcutaneous fat, but remains investigational. The useful next question is whether larger blinded studies reproduce the effect with acceptable tolerability and durability.

Published Phase 2b — CBL-0204 / NCT05736107. The May 20, 2026 paper randomized 108 adults, BMI between 18.5 and 30, to CBL-514 or placebo. MRI fat-volume change was −20.3% versus +0.1% four weeks after final treatment, and −17.3% versus +0.7% at 12 weeks. These percentages describe the assessed abdominal depot, not total body fat or weight. Clinician-rated improvement favored treatment, but investigators were unblinded, 38.9% discontinued early, and available analysis samples were smaller than the randomized sample. Injection-site reactions were common; pain occurred in 73.1% versus 36.4%, and some participants stopped for local reactions. The paper excluded visible abdominal panniculus, so it does not establish treatment of loose skin. These results warrant further trials, not a guaranteed personal outcome. Full primary paper.

Pivotal development — SUPREME-01 / CBL-0301 / NCT07140939. The registry snapshot last updated March 30, 2026 describes approximately 300 participants in a randomized placebo-controlled Phase 3 trial, with estimated primary completion in May 2027. It still says not yet recruiting; this conflicts with later sponsor announcements. Caliway's August 31 report says enrollment has begun and explains an updated primary endpoint based on two-grade improvement on both patient and clinician abdominal-fat rating scales, with MRI volume as a key secondary endpoint. Treat the registry date as an older estimate and the enrollment/endpoint changes as newer sponsor-reported information. Registry; August 31 sponsor update.

GLP-1 combination — CBL-0201WR. The August 25 sponsor release reports IND clearance for a randomized Phase 2 CBL-514 plus tirzepatide study targeting 120 U.S. participants. This permits human testing; it is not marketing approval or a human efficacy result. Weight-regain claims remain to be tested. Sponsor trial announcement.

Expected next update. Caliway announces an EASD presentation on September 30, 2026, on visceral-fat findings. The human analysis and preclinical contributions need appraisal when the abstract is available. For pivotal results, 2027 is a sponsor target: Caliway’s May 22, 2026 release anticipates SUPREME toplines during 2027. The older May 2027 primary-completion estimate is not a promised release date. Pivotal-program guidance. No reliable combination-trial readout date was verified. September 30 announcement.

Coverage limits. The registry's indexed primary record was readable, but the live detail/API rendering was unreliable. Enrollment and protocol changes therefore retain explicit sponsor attribution. Reconcile them with a newer registry version at the next check. A focused September 13, 2026 live API check recovered the same March 30 record; the newer sponsor enrollment and protocol announcements remain unreconciled with the registry.

Retreatment and durability — CBL-0206. The June 4 registry snapshot for Stage 1 / NCT07608770 lists a recruiting, randomized placebo-controlled Phase 2b study targeting approximately 250 adults, with MRI fat-volume endpoints and estimated primary completion in April 2027. The May 29 record for Stage 2 / NCT07608757 describes an open-label, single-group retreatment extension, despite retaining the broader randomized-study wording in its title. It estimates a February 2027 start and February 2028 primary completion. These are registry estimates, not release dates. Both records exclude severe visceral fat; neither should be treated as established treatment evidence for that population.

Related local-fat indications. Track major human results for CBL-514D in Dercum's disease lipomas and CBL-514 for cellulite as secondary programs, with their disease-specific endpoints. CBL-0202DD / NCT06303570 lists 19 participants and actual primary completion on March 23, 2026. Caliway's August 31 update targets September 2026 topline results. Cellulite Phase 2 topline was announced in April 2024; a dependable next readout date was not verified. Painful-lipoma or cellulite improvement is not interchangeable with general abdominal-fat reduction.

Visceral-fat presentation. The September 30 EASD presentation is sponsor-announced. The August 25 release describes MRI-measured VAT findings, while August 31 also emphasizes preclinical work. The actual abstract, human sample and analysis were not verified in this expansion check; inspect them before interpreting the presentation as a new human VAT efficacy result.

Established comparator. Kybella (deoxycholic acid) is FDA-approved for submental fullness in adults. Its label does not establish safe and effective use elsewhere. Keep it as context and watch major formal new-indication developments. Current DailyMed label.

Program. RZL-012, also indexed as utenpanium chloride and tapencarium, is an investigational local fat-reduction injection from Raziel. Follow chin fat and body-contouring development separately. NLM compound aliases; U.S. Phase 2b chin study / NCT04867434; small flank study / NCT05445557.

Latest evidence — sponsor topline, September 2, 2026. Raziel and Fosun report a placebo-controlled China Phase 3 trial in 480 participants (360 active, 120 placebo). At day 84, the primary responder rate favored treatment by 30 percentage points; this does not mean 30% fat-volume reduction. The release reports that endpoints were met but provides limited detailed safety and durability data. Full results are needed to appraise the effect and harms. Sponsor announcement.

Next milestone and U.S. status. The sponsors target a China NDA submission by end-2026 and plan a body-contouring trial, without a verified start date. These are plans, not approvals. No U.S. approval or dependable U.S. pivotal-readout date was verified. Track the full Phase 3 publication, China filing/acceptance, and the new body-site protocol.

Earlier safety context. Posted U.S. Phase 2b results include 151 actual participants, rather than the originally planned 135. Dysphagia was reported in 15/50 high-dose recipients, 21/53 low-dose recipients and 2/48 placebo recipients; facial paralysis in 3/50, 1/53 and 0/48, respectively. No serious adverse events or deaths were reported. These events require attention when interpreting broad sponsor safety claims. The registry results and published Phase 2b paper provide the starting evidence; the 12-person flank study is much earlier body-area evidence.

Program and evidence. AMIpharm's AYP-101 is a phosphatidylcholine formulation studied for chin fat. A published Phase 2 randomized trial enrolled 96 Asian adults; at four weeks, evaluator-rated improvement occurred in 69.70% of the lower-dose group versus 22.58% with placebo. This is the evaluator scale, not a verified combined evaluator-and-patient response. Small size, short follow-up and a chin-specific population limit generalization. Claims of superior tolerability to deoxycholic acid based on separate trials are not head-to-head evidence. Peer-reviewed report / PMID 40850886.

Current stage and timing. Phase 3 / NCT06256445 enrolled 252 participants and completed October 30, 2025. The registry's January 22, 2026 update has no posted results. Watch Phase 3 results and regulatory progress; no dependable release date or U.S. milestone was verified. This formal investigational formulation should not be conflated with gray-market phosphatidylcholine injection mixtures. Registry API record.

Overseas comparator. Medytox lists cholic-acid injection MT921/NUVIJU as approved by Korea's MFDS. Keep overseas label changes or new body-site trials as secondary watch items; no U.S. milestone was verified. Medytox development page.

Approved use. Tesamorelin stimulates the growth-hormone axis; it is not a local fat-dissolving injection. EGRIFTA is FDA-approved for excess abdominal fat in adults with HIV-associated lipodystrophy. EGRIFTA WR's 2025 approval changed preparation convenience, not the indication. The label describes weight neutrality and unestablished long-term cardiovascular safety, with monitoring concerns including elevated IGF-1 and glucose intolerance. General-obesity, non-HIV VAT and MASLD/MASH use are not approved indications. FDA EGRIFTA WR label.

Human evidence beyond HIV. A 12-month randomized placebo-controlled trial in 60 adults with abdominal obesity and reduced growth-hormone secretion found a VAT treatment effect of −35 cm² (95% CI −58 to −12), without significant subcutaneous-fat reduction. This selected population and surrogate endpoint do not establish general effectiveness or cardiovascular-event prevention. NCT00675506 / published 2012 trial.

Liver-fat research. In a separate 61-person randomized trial of HIV-associated fatty liver, tesamorelin reduced liver fat by 4.1 percentage points versus placebo at 12 months; existing fibrosis did not significantly improve. This is liver-fat evidence, not proof of MASH resolution or improved clinical liver outcomes. NCT02196831 / published 2019 trial.

Non-HIV fatty liver — NCT03375788. Massachusetts General Hospital's completed Phase 2 trial randomized 51 participants (26 tesamorelin, 25 placebo); 38 finished the 12-month randomized phase. Posted results, dated November 20, 2025, include only 18/16 participants in the primary liver-fat analysis. Median changes were −5.3 versus +3.6, labeled “percent change in hepatic fat fraction”; the registry does not resolve relative percent versus percentage points or supply a statistical comparison. Median activity-score and fibrosis-score changes were zero in both groups. No numerical VAT outcome is posted. Serious adverse events affected 2/26 versus 3/25; other adverse events 22/26 versus 15/25, with more arthralgia, edema and injection-site stinging in the tesamorelin group. These are small, incomplete-analysis registry results, not proof of general VAT or clinical liver-outcome benefit. Registry and results; verified API; protocol.

New-indication development and next update. The sponsor's historical general-population NASH Phase 2b/3 proposal was awaiting a partner, with FDA protocol questions left unresolved in its filing. No current trial launch, broader indication decision or reliable future readout date was verified. Watch full publication and clarification of the posted non-HIV results, a funded follow-on trial, registration and first enrollment. Keep that proposed commercial program separate from the completed academic trial. Sponsor filing.

Registry quality check. NCT07481734 explicitly identifies itself as a “Mock Study”; do not count it as a real tesamorelin development milestone. Record.