Drug evidence profileInvestigational - not FDA approved

ZUPREME trial: Petrelintide results, Phase 3, and current status.

Also searched as ZP8396 · long-acting amylin analogue

Petrelintide is Zealand Pharma and Roche’s investigational once-weekly amylin analogue for chronic weight management. Its Phase 2 story combines double-digit mean loss with a detailed tolerability record, while Phase 3 initiation is planned for the second half of 2026 rather than already confirmed by a recruiting pivotal-trial record.

Approval and access

Is petrelintide already in Phase 3 or available to buy?

Zealand Pharma and Roche have formally endorsed advancing petrelintide to Phase 3 and say chronic-weight-management trials are planned to start in the second half of 2026. At this evidence check, that is a planned milestone rather than a published Phase 3 outcome. Petrelintide is not FDA approved and has no legitimate commercial label, prescription price, or retail pharmacy channel. A product sold online under an investigational name should not be treated as the clinical-trial material studied by the sponsors.

Live decision workspace

Compare Petrelintide with Retatrutide, without losing the country context.

Put evidence status, ClinicalTrials.gov coverage, official United States records, and qualified US research prices in one view. Blank fields stay blank when the underlying dataset does not support a number.

AIdentity record
Petrelintide

Investigational clinical program

No linked research price board
Destination fixedUnited StatesNorth America

Official product and seller records attached

BComparison record
Retatrutide

Investigational clinical program

No linked research price board
01 · Status02 · Trials03 · Country04 · Price
Current program snapshot

What can you conclude about Petrelintide today?

These are dated program facts, not a cross-trial ranking, approval forecast, personal treatment recommendation, or proof that a same-name online product is the sponsor's medicine.

Drug classAmylin analogue

A long-acting investigational analogue designed for once-weekly subcutaneous administration.

ZUPREME-1Up to 10.7% at 42 weeks

Estimated mean loss under the efficacy estimand versus 1.7% with pooled placebo in Phase 2.

Pooled nausea19.6% vs 6.2%

ADA poster rate for pooled petrelintide versus pooled placebo; dose-specific rates varied.

Next stagePhase 3 planned H2 2026

Zealand and Roche formally endorsed advancement; initiation timing remains a forward plan until trial records confirm it.

Marketing and authorization statusInvestigational - not FDA approved
Evidence checked July 17, 2026Open lead source
Program identity

Know which molecule the result belongs to.

Sponsor
Zealand Pharma + Roche
Mechanism
Long-acting amylin analogue
Route being studied
Once-weekly subcutaneous injection
Current stage
Phase 3 planned; Phase 2 program active
Featured trial anchors
NCT06662539 · NCT06926842 · NCT07589686
Evidence checked
July 17, 2026
Sourced weight-loss trial results

Petrelintide weight-loss results, with the trial attached.

This visual shows one selected result, not every dose or endpoint in the program. The percentage remains attached to its duration, population, comparator, analysis method, and source.

Evidence checked July 21, 2026
Phase 2Weekly injection
NCT06662539
10.7%Active-arm mean
ZUPREME-142 weeks

Petrelintide reported 10.7% mean reduction at 42 weeks under the efficacy estimand, upper end of five dose-group estimates. The comparator recorded 1.7% mean reduction.

Petrelintide reported mean10.7%
Comparator mean1.7% mean reduction

Bar lengths share a 0 to 30% visual scale. They describe this selected record and do not make separate trials head-to-head.

Population
Adults with obesity or overweight and weight-related complications
Participants
493 Total randomized trial population
Dose
Upper reported dose-group result
Primary analysis
Efficacy estimand, upper end of five dose-group estimates
Regulatory status
Investigational; not FDA approved
ClinicalTrials.gov program landscape

Petrelintide clinical trials by status, phase, and location.

The current exact-intervention snapshot matches 9 unique NCT records. This chart describes registry coverage and current study fields. It does not compare efficacy, safety, approval probability, eligibility, or treatment access.

Snapshot 2026-07-24
9matched NCT records
2overall Recruiting
0registry results posted
4recruiting site observations
3countries with recruiting sites
Registry phase mix2 phase labels
Phase labels come from ClinicalTrials.gov. A larger phase count is not stronger evidence or a better program.
Registry geographyTop current recruiting-site observations

Counts use individual locations currently marked Recruiting, not every facility listed on an overall-recruiting study. Repeated centers across studies remain repeated site observations.

Countries6 represented
01Slovakia1 recruiting study2 sites02Poland1 recruiting study1 sites03South Korea1 recruiting study1 sites04United States0 recruiting studies0 sites05Romania0 recruiting studies0 sites06Germany0 recruiting studies0 sites
United States28 states represented
01Florida0 recruiting studies0 sites02Texas0 recruiting studies0 sites03North Carolina0 recruiting studies0 sites04California0 recruiting studies0 sites05Arizona0 recruiting studies0 sites06Georgia0 recruiting studies0 sites
Worldwide status map

Petrelintide across 42 countries.

This profile establishes the program identity and its cited clinical or regulatory record. It does not turn a same-name seller listing into the sponsor’s asset or prove authorization, availability, or lawful supply in another destination.

Compare Petrelintide by country →Compare Petrelintide by US state →Browse the global peptide country dataset →
Country-specific status checks

Is Petrelintide approved or available in your country?

Start with the United States FDA record, then check the destination that matters to you. Each country page separates drug identity, authorization, product records, seller claims, and supply rules. Directory checked July 20, 2026.

Evidence ledger

What the record shows - and what it doesn’t.

Trial percentages are kept beside the design details that make them interpretable. Unknowns stay visible instead of being filled with launch speculation.

Supported
01

ZUPREME-1 was a 42-week dose-finding trial

The randomized Phase 2 study enrolled adults with obesity or overweight without type 2 diabetes. Zealand’s ADA materials report estimated mean losses from 8.7% to 10.7% across five petrelintide groups at week 42 under the efficacy estimand, compared with 1.7% for pooled placebo.

02

The tolerability record needs exact rates

In the ADA presentation, pooled nausea occurred in 19.6% of petrelintide participants versus 6.2% with placebo, diarrhea in 7.4% versus 7.4%, constipation in 6.9% versus 3.7%, and vomiting in 3.0% versus 6.2%. The sponsor’s ‘placebo-like’ summary should be read beside those event-specific data and the five dose groups.

03

Development extends beyond one population

ZUPREME-2 is a separate 28-week Phase 2 trial in adults with overweight or obesity and type 2 diabetes, with an active, not recruiting record at this check. Zealand and Roche also announced plans to begin Phase 3 chronic-weight-management trials in the second half of 2026.

Not established
01

Phase 3 outcomes do not exist yet

A sponsor decision to advance and a pipeline label are not Phase 3 efficacy or safety results. Pivotal designs, enrolled populations, doses, estimands, completion dates, and outcomes must be read from future trial records and results rather than projected from Phase 2.

02

No approved commercial product

Petrelintide has no FDA-approved indication, label, retail price, pharmacy channel, or coverage policy. The once-weekly schedule is the schedule under study, not a consumer dosing instruction or evidence that online products bearing the name are authentic.

03

Durability and comparative position are unresolved

ZUPREME-1 does not establish what happens after long-term discontinuation or whether petrelintide is more tolerable, more effective, or more sustainable than an approved GLP-1 medicine. Those questions require suitably designed longer and comparative trials.

Direct answers

The questions behind the search.

Concise answers based on the dated sponsor and trial records below. This is educational reporting, not medical advice.

01

What is petrelintide and how is it different from a GLP-1 drug?

Petrelintide, formerly ZP8396, is an investigational long-acting analogue of amylin, a hormone co-secreted with insulin after nutrients are consumed and involved in satiety signaling. It is being studied as a once-weekly injection. It does not use the same primary receptor mechanism as a GLP-1 receptor agonist, although both classes are being investigated for weight management. That mechanistic difference is scientifically useful; it does not by itself prove superior efficacy, tolerability, muscle preservation, or long-term persistence.

02

What did the ZUPREME-1 petrelintide trial show?

In the sponsor’s ADA 2026 materials, five petrelintide dose groups had estimated mean weight reductions of 8.7% to 10.7% at week 42 under the efficacy estimand, compared with 1.7% for pooled placebo. The trial included 485 participants in the presented analysis, without type 2 diabetes, and used dose escalation followed by maintenance. Pooled nausea was 19.6% with petrelintide versus 6.2% with placebo, while several other gastrointestinal event rates were closer. Those details are more informative than a single ‘placebo-like’ slogan.

03

Is petrelintide already in Phase 3 or available to buy?

Zealand Pharma and Roche have formally endorsed advancing petrelintide to Phase 3 and say chronic-weight-management trials are planned to start in the second half of 2026. At this evidence check, that is a planned milestone rather than a published Phase 3 outcome. Petrelintide is not FDA approved and has no legitimate commercial label, prescription price, or retail pharmacy channel. A product sold online under an investigational name should not be treated as the clinical-trial material studied by the sponsors.

Important boundaryApproval status is jurisdiction-specific.

Do not use an investigational name, trial dose, or online research listing as a substitute for approved care. This page does not recommend treatment, sourcing, or participation in a clinical trial.

Understand the product-category boundary →
Primary referencesPetrelintide development profileMechanism, route, partnership, program status, and planned Phase 3 timingZealand Pharma · Record checked July 17, 2026ZUPREME-1 ADA 2026 poster and slidesTrial design, 42-week dose-group estimates, pooled adverse-event rates, and analysis definitionsZealand Pharma · June 2026ZUPREME-1 Phase 2 study - NCT06662539Randomized design, population, sponsor, route, endpoints, and study recordClinicalTrials.gov · Record checked July 17, 2026ZUPREME-2 Phase 2 study - NCT06926842Type 2 diabetes population, 28-week design, enrollment, and active record statusClinicalTrials.gov · Record checked July 17, 2026ZUPREME-1 detailed results and Phase 3 planSponsor interpretation, chronic-weight-management Phase 3 plan, and partnership contextZealand Pharma · June 5, 2026