Petrelintide
Petrelintide is an investigational once-weekly amylin analogue developed by Zealand Pharma. A phase 2 trial showed up to about 10% weight loss with mostly mild nausea, and Roche has started phase 3 trials. It is not approved.
Petrelintide (formerly ZP8396)
Also searched as: ZP8396.
Educational information. This page does not give dosing instructions or tell you what to take. Ask a prescriber about your own care.
In plain English
Petrelintide (also ZP8396) is an amylin analogue from Zealand Pharma. The pitch is gentler tolerability: the phase 2 trial found stomach side effects close to placebo apart from mostly mild nausea during dose increases.
In ZUPREME-1, 485 adults without diabetes lost an average of 7.9% to 9.8% of body weight at 28 weeks on the different weekly amounts, versus 1.7% on placebo. Weight was still falling at week 42, reaching up to 10.7%. That is lower than the roughly 20% seen with some other amylin-based drugs, though those trials ran longer.
Hoffmann-La Roche is listed as the sponsor of new phase 3 trials that began in September 2026, including one with about 3,900 people. Petrelintide is not approved anywhere.
Brand names and products
A generic name identifies the drug itself. A brand name identifies one company's product. One drug can come in several products with different forms and approved uses, so the brand name often tells you more about what a prescription is for.
No brand name is recorded for this medicine because there is no approved product.
Approved and investigational. Every use of petrelintide is investigational. There is no approved product.
How it works
Petrelintide is a long-acting version of human amylin. Natural amylin slows stomach emptying and helps people feel full sooner. It works through the amylin pathway rather than GLP-1, so it is being studied alone and alongside other drugs, including a planned phase 2 combination trial with a Roche medicine called enicepatide.
Forms and approval status
| Form | How it is taken | U.S. status |
|---|---|---|
| Petrelintide injection (investigational) | Once weekly in trials. Available only inside clinical trials. | Not approved. Hoffmann-La Roche is the registered sponsor of three phase 3 trials that started recruiting in September 2026: one in overweight or obesity (3,900 people), one with type 2 diabetes (600) and one with established cardiovascular disease (2,500). |
What the trials found
These are group averages from published trials in adults without diabetes unless stated. See how to read trial numbers before comparing.
ZUPREME-1 (petrelintide)
Average change in body weight. Every bar uses one scale, 0 to 25 percent.
- People studied
- 485 treated adults without type 2 diabetes, with a BMI of 30 or more, or 27 or more plus high blood pressure or abnormal cholesterol
- Length
- 28 weeks
- Compared with
- Placebo. Five weekly amounts from 1.0 to 9.0 mg, given over 42 weeks including dose increases. The main comparison was set at week 28
- What was measured
- Average change in body weight at week 28
- Analysis approach
- Efficacy estimand: effects while people were taking the treatment as assigned. Missing data were assumed to be missing at random
- Other results
- The 2.5 mg and 7.0 mg groups lost 7.9% and 9.3%. Weight kept falling to week 42, by up to 10.7% on petrelintide.
- Safety
- Nausea was the most common side effect: 20% on petrelintide vs 6% on placebo, mostly mild and during dose increases. Vomiting (3% vs 6%), diarrhea (7% vs 7%) and constipation (7% vs 4%) were low. No deaths were reported.
- Limits
- Phase 2 and a short main comparison at 28 weeks. Funded by the manufacturer. Weight loss at 28 weeks is well below the roughly 20% seen in some other amylin-based trials, though those ran longer and are not head-to-head. Participants and staff knew which maintenance amount was assigned, though not whether it was active drug or placebo. Group averages do not predict one person's result.
Sources: Garvey WT 2026
Safety
No FDA label exists for this medicine yet. The information below comes from published trial reports. The points below are a summary and may be incomplete.
Boxed warning and label notes
- Petrelintide injection (investigational): Not applicable. Not approved.
Warnings labels describe
- Not approved, so no official label exists. Safety information comes from trial reports.
- The main phase 2 comparison lasted 28 weeks, so longer-term safety is unknown.
Most common in trials
- Nausea, mostly mild and during dose increases
- Constipation
- Diarrhea
Less common but serious
- No deaths were reported in ZUPREME-1. The abstract does not list serious events.
What is still unknown
- Phase 3 results. Those trials started in September 2026 and the registered primary completion dates run from late 2028.
- Results of ZUPREME-2, the phase 2 trial in type 2 diabetes. The registry lists it as complete, and results were not found.
- Whether weight loss continues past 42 weeks and how large it ultimately gets.
- How it compares with eloralintide, cagrilintide or incretin drugs. No head-to-head trial exists.
- The best amount. The 5 mg group did about as well as the 9 mg group in phase 2.
Compiled from public information: FDA-approved labels, manufacturer websites, ClinicalTrials.gov and published journal articles. Sources are listed at the bottom of this page.
Sources
- Petrelintide, a human amylin analogue for the treatment of obesity (ZUPREME 1): a randomised, double-blind, placebo-controlled, phase 2 trial Garvey WT, et al. Lancet Diabetes Endocrinol. 2026;14(11):914-926. PMID 42810355. Funding: Zealand Pharma. Journal article
- Petrelintide phase 3 in overweight or obesity (NCT07843498) ClinicalTrials.gov identifier NCT07843498. Sponsor: Hoffmann-La Roche. Trial registry
- ZUPREME 2: petrelintide phase 2 in obesity with type 2 diabetes (NCT06926842) ClinicalTrials.gov identifier NCT06926842. Sponsor: Zealand Pharma. Trial registry
- ClinicalTrials.gov U.S. National Library of Medicine. Trial registry
- Amylin analogs: the next major class of weight loss therapy? A review of experimental data and early-phase clinical trials Alhazmi A, le Roux CW. Diabetes Obes Metab. 2026;28 Suppl 5:42-50. PMID 42452898. Funding: Not stated in the abstract. Journal article