ZUPREME-1 primary publication: nausea 79/404 active versus 5/81 placebo; vomiting 12/404 versus 5/81. Pooled across doses; no head-to-head safety claim.
10.7% reported weight loss · 1.7% loss with placebo · 42 weeks
Maximally effective once-weekly dose; dose level not specified in release
Adults with obesity or overweight and comorbidity; no type 2 diabetes
Efficacy estimand; week 42 secondary/exploratory endpoint, primary at week 28. Primary publication clarifies 493 randomized and 485 treated; this historical figure reports the treated cohort. Investigational; the phase 3 program has begun treatment. No U.S. obesity approval established.
Safety context
ZUPREME-1 primary publication: nausea 79/404 active versus 5/81 placebo; vomiting 12/404 versus 5/81. Pooled across doses; no head-to-head safety claim.
Limitations: Sponsor/conference report; treatment-policy numerical estimate not provided in this source. The September 29 paper adds dose-specific 28-week estimates. These do not replace this historical 42-week result or establish its undisclosed milligram-dose mapping.
Investigational; no approved trade name identified as of 2026-09-13. Petrelintide and the earlier code ZP8396 are not approved brands.
Zealand Pharma · Originator and co-development partner; shared commercialization with Roche in the US and Europe.; Roche · Co-development partner; shared commercialization in the US and Europe, exclusive commercialization elsewhere; responsible for commercial manufacturing and supply.
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
The molecule
A long-acting human amylin analogue with balanced activation of amylin and calcitonin receptors.
Structure not yet verified
Structure not verified
A long-acting human amylin analogue with balanced activation of amylin and calcitonin receptors.
Shown: Peptide drug
The downloaded PubChem biological diagram has unexpanded or clipped modification labels, so it was withheld rather than shown as a complete drug structure.
ZUPREME-1 publication adds exact doses, uncertainty and gastrointestinal event counts
The September 29 paper supplies dose-specific weight estimates and harms; it is separate from October 7 ZUPREME-2 diabetes topline. Phase 3 recruitment underway; no additional promised results date. Full methods/safety supplement remains pending.
October 7 sponsor confirms first participants treated in the phase 3 program. ZUPREME-3 and -5 registries report September 30 actual starts; ZUPREME-4 retains an estimated September 30 start. These are three separate weight-endpoint protocols, not proven cardiovascular benefit.
At 28 weeks the sponsor reports efficacy-estimand weight loss 7.4–9.2% versus 2.0% and maximum HbA1c reduction 0.65 percentage points versus a 0.23-point placebo increase. Dose mapping, arm counts and intervals were not disclosed; GI discontinuation is pooled. No head-to-head comparison or diabetic approval.