Model-based efficacy-estimand endpoint from slide 9; not the observed means in the connecting line plot and not the publication’s primary treatment-regimen weight estimate. Investigational; not FDA-approved.
Safety context
TRIUMPH-2 12 mg: diarrhea 34%, nausea 28%, hypotension 6%, dysesthesia 7%; permanent discontinuation due to adverse events or death 8%, versus 5% with placebo. Corresponding placebo event rates were 13%, 8%, <1% and 1%. Deaths occurred in all groups and investigators considered them unrelated to treatment.
Limitations: Highest planned dose, not largest HbA1c response: 9 mg decreased HbA1c 1.63 pp and 4 mg 1.41 pp in the same efficacy analysis. The trial primary endpoint was weight change. This longer diabetes/obesity cohort is separate from TRANSCEND-T2D-1; no head-to-head ranking across studies is justified.
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
The lipidated 39-residue retatrutide molecule, including nonstandard residues and its linker/lipid branch.
Shown: Retatrutide molecule; not a sodium-salt substitute.
This full atom-and-bond diagram is dense; use a compact preview with an enlarge option. It is a two-dimensional connectivity diagram, not a 3D conformation. Identity is established by the IUPHAR-deposited retatrutide substance and its standardized compound mapping.
July 23 target reiterated August 5, 2026; not an FDA decision deadline.
Lilly targets a retatrutide Biologics License Application in Q1 2027. Its August update reiterates the target after completion of the clinical package for obesity, obstructive sleep apnea and knee osteoarthritis pain.
The sponsor says chemistry, manufacturing and controls work is part of the remaining package. Filing, FDA acceptance, benefit-risk review and approval are separate milestones.
Lilly reported TRIUMPH-4 toplines in people with obesity and knee osteoarthritis. These are sponsor disclosures from a selected population, not the general-obesity chart trial.
Lilly disclosed phase 3 findings at 80 weeks in adults with obesity or overweight without diabetes; the disclosure date is not the study-completion date.
In 1,152 adults, 12 mg weekly reduced weight 18.8% versus 5.1% with placebo at 80 weeks using the primary treatment-regimen estimand. Each reported 0.7 uncertainty value is a standard error. The diabetes-selected cohort is kept separate from the TRIUMPH-1 non-diabetic weight map; GI events, hypotension, dysesthesia and treatment discontinuation remain important.
The 2,339-person non-diabetic trial publication adds diagnosis-specific OSA and knee-pain substudies. AHI and pain are separate from cardiovascular benefit and cartilage repair. The indexed abstract was appraised; full safety/supplements remain an access gap. Existing weight estimates and historical curves are preserved.