Petrelintide
Petrelintide is a once-weekly injectable amylin analog under investigation for overweight and obesity. In the Phase 2 ZUPREME-1 dose-finding trial (about 493 participants) once-weekly petrelintide met its primary endpoint with clinically meaningful weight loss and a gastrointestinal tolerability profile the sponsors described as favorable. The evidence to date comes from Phase 1 and Phase 2 studies reported by the companies and at scientific meetings, with peer-reviewed publication of the pivotal data still pending. It is not approved and is available only through clinical trials.
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Mechanism
In plain terms, petrelintide imitates amylin, a hormone released alongside insulin that signals fullness and slows stomach emptying, which reduces how much a person eats. Technically, it is a long-acting amylin receptor agonist engineered for once-weekly subcutaneous dosing; by activating amylin receptors it promotes satiety and is being studied as a weight-management therapy, including in combination with other agents.
Regulatory Status by Region
- United States (FDA)Not approved. Investigational and in clinical development for chronic weight management.
- Australia (TGA)Not registered on the ARTG. Investigational only.
- European Union (EMA)Not authorised. Investigational only.
- WADANot listed as a prohibited substance on the WADA Prohibited List (2026). Amylin analogs are not classified as prohibited in or out of competition.
Key Studies
- ZUPREME-1 (ZUPREME): Phase 2 dose-finding trial of once-weekly petrelintide in obesity or overweight (opens in a new tab) (ClinicalTrials.gov NCT06662539; sponsor Zealand Pharma; 493 participants; Phase 2; completed)
- ZUPREME-2: Phase 2 trial of petrelintide in overweight or obesity with type 2 diabetes (opens in a new tab) (ClinicalTrials.gov NCT06926842; sponsor Zealand Pharma; 221 participants; Phase 2)
- Roche and Zealand Pharma Phase 2 (ZUPREME-1) topline results announcement (opens in a new tab) (Roche media release, 5 March 2026; up to 10.7% mean weight reduction at week 42 versus 1.7% with placebo)
Related Clinical Trials
- A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or OverweightPhase 2 · Not Yet Recruiting
- Investigating the Pharmacokinetics of Petrelintide Using Different Drug Product ConcentrationsPhase 1 · Completed
- Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes (ZUPREME 2)Phase 2 · Active Not Recruiting
- Pharmacokinetics of Petrelintide Following Administration to Participants With Impaired Renal FunctionPhase 1 · Completed
- Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum DisorderPhase 2 · Recruiting
- Once-weekly Petrelintide Versus Placebo for Obesity or Overweight With Co-morbiditiesPhase 2 · Completed
- A Research Study Looking at the Safety of Multiple Doses of ZP8396 and How it Works in the Body of Healthy ParticipantsPhase 1 · Completed
- A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial ParticipantsPhase 1 · Completed
Latest research
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials. (opens in a new tab)
Diabetes, obesity & metabolism · Jul 1, 2026
Common Questions
- What is Petrelintide?
- Petrelintide is an investigational long-acting amylin analog being developed by Zealand Pharma and Roche for chronic weight management. It is not approved by any regulator. In the Phase 2 ZUPREME-1 trial it produced up to about 10.7% mean body-weight reduction at week 42 versus 1.7% with placebo, and the companies plan to advance it into Phase 3.
- Is Petrelintide approved for medical use?
- Petrelintide is investigational: it is being studied in clinical research and is not an approved medicine. United States (FDA): Not approved. Investigational and in clinical development for chronic weight management. European Union (EMA): Not authorised. Investigational only. Australia (TGA): Not registered on the ARTG. Investigational only.
- How does Petrelintide work?
- In plain terms, petrelintide imitates amylin, a hormone released alongside insulin that signals fullness and slows stomach emptying, which reduces how much a person eats. Technically, it is a long-acting amylin receptor agonist engineered for once-weekly subcutaneous dosing; by activating amylin receptors it promotes satiety and is being studied as a weight-management therapy, including in combination with other agents.
- Is Petrelintide legal in Australia?
- Petrelintide in Australia (TGA): Not registered on the ARTG. Investigational only.
- Is Petrelintide banned in sport?
- Petrelintide under the World Anti-Doping Agency (WADA) code: Not listed as a prohibited substance on the WADA Prohibited List (2026). Amylin analogs are not classified as prohibited in or out of competition.