Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library · Trial & Regulatory Tracker →

Petrelintide (ZP8396): what the evidence says

Name: Petrelintide (ZP8396)
Published: 2026-10-27

At a glance

What it is: a lab-made, long-acting analogue of the human satiety hormone amylin, injected once a week. Made by Zealand Pharma, co-developed with Roche since 2025. ^{R1, R2}

What the evidence says: in the 493-person ZUPREME-1 phase 2 RCT, weight fell 7.9% to 9.8% at 28 weeks vs 1.7% on placebo, and up to 10.7% by week 42. ^R3 Phase 1 trials showed a half-life of about 10 days. ^R4 Not approved anywhere.

Biggest risks: mostly mild nausea during dose increases (20% vs 6%); vomiting was uncommon. ^R3

Rating


Human Human evidence	Moderate for weight loss (one phase 2 RCT, sponsor-run) ^R3 · Limited phase 1 safety and drug levels ^R4
Animal Animal / lab evidence	Chemistry and rodent potency work ^R1
Regulatory	Investigational · not on the 503A/503B lists or FDA's safety-risk page · not named on WADA's 2026 list ^{R5, R6, R7, R8}
Established human dose	None (investigational). Study details lists what trials used

Evidence verdict: Weight loss in obesity: Moderate (one phase 2 RCT plus phase 1, investigational) · Anything else: No human data

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: both clinical papers were funded by Zealand Pharma. ZUPREME-1 masked active vs placebo but not the dose levels; 86% of participants were White. ^{R3, R4}

What is it?

Amylin is released with insulin after meals and signals fullness. Petrelintide is a stabilized amylin analogue built for neutral-pH formulation, so it can be co-formulated with other drugs. ^R1 Related pages: Cagrilintide, CagriSema, Pramlintide, Semaglutide.

Does it work?

Human ZUPREME-1 (Garvey 2026): 493 randomized at 32 sites in Poland, Romania and the US; placebo-adjusted weight loss 6.2% to 8.1% at 28 weeks. ^{R3, R9}
Human Phase 1 (Brændholt Olsen 2026): weight fell up to 8.6% after 16 weeks in the multiple-dose study. ^R4
Unknown No data yet on heart, diabetes or long-term outcomes.

Is it safe?

Human ZUPREME-1: nausea 20% vs 6%; vomiting 3% vs 6%; diarrhea and constipation similar to placebo; no deaths. ^R3
Human Phase 1: no serious or severe adverse events. ^R4
Unknown No data beyond 42 weeks.

Gray-market "petrelintide": extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Pipeline (sponsor, trials, expected readouts)

Sponsors: Zealand Pharma and Roche . ^R2
ZUPREME-2 (NCT06926842): obesity with type 2 diabetes, phase 2; primary completion Aug 2026; results expected but not published as of Oct 26, 2026. ^R10
Phase 3 (NCT07843472, NCT07843485, NCT07843498): Roche-led, recruiting from Sept 30, 2026; primary completions listed Oct 2028 to Jul 2030. ^{R11, R12, R13}
Combination: dose-finding with Roche's enicepatide (NCT07589686), not yet recruiting. ^R14

What we don't know

Unknown Long-term weight maintenance and safety
Unknown How it compares head-to-head with GLP-1 drugs

Is it legal?

US (FDA): investigational; not approved and not available by prescription. Not on the compounding lists. ^{R5, R6}
Athletes: not named on WADA's 2026 list. UNVERIFIED whether WADA's S0 (unapproved substances) clause would apply. ^R8

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
ZUPREME-1 (Garvey 2026)	485 adults with obesity, no T2D	SC weekly	1.0, 2.5, 5.0, 7.0 or 9.0 mg maintenance	42 weeks	−7.9% to −9.8% at 28 weeks	PMID 42810355
Phase 1 SAD	Healthy / overweight adults	SC; one IV arm	0.04 to 2.4 mg SC; 0.35 mg IV	Single dose	Half-life ~10 days	PMID 42017294
Phase 1 MAD	Overweight/obese adults	SC weekly	Escalated to 2.4, 4.8 or 9.0 mg	16 weeks	Up to −8.6%	PMID 42017294

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Fischer Munch H, et al. J Med Chem. 2025. PMID 41217931
^R2 Roche, Roche and Zealand Pharma enter collaboration to co-develop and co-commercialise petrelintide, Mar 12, 2025. https://www.roche.com/media/releases/med-cor-2025-03-12; closing announced by Zealand Pharma May 9, 2025: https://www.globenewswire.com/news-release/2025/05/09/3077929/0/en/zealand-pharma-announces-closing-of-collaboration-and-license-agreement-with-roche.html
^R3 Garvey WT, et al. Lancet Diabetes Endocrinol. 2026. PMID 42810355
^R4 Brændholt Olsen M, et al. Diabetes Obes Metab. 2026. PMID 42017294
^R5 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R6 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R7 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R8 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R9 ClinicalTrials.gov NCT06662539, Zealand Pharma, ZUPREME-1, petrelintide vs placebo in obesity, phase 2, completed (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT06662539
^R10 ClinicalTrials.gov NCT06926842, Zealand Pharma, ZUPREME-2, petrelintide in obesity with type 2 diabetes, phase 2, completed, primary completion Aug 2026 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT06926842
^R11 ClinicalTrials.gov NCT07843472, Hoffmann-La Roche, petrelintide phase 3, recruiting, start Sept 30, 2026, primary completion Jul 2030 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT07843472
^R12 ClinicalTrials.gov NCT07843485, Hoffmann-La Roche, petrelintide phase 3, recruiting, primary completion Oct 2028 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT07843485
^R13 ClinicalTrials.gov NCT07843498, Hoffmann-La Roche, petrelintide phase 3, recruiting, primary completion Dec 2028 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT07843498
^R14 ClinicalTrials.gov NCT07589686, Hoffmann-La Roche, petrelintide with enicepatide (RO7795068) dose-finding, phase 2, not yet recruiting (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT07589686

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Petrelintide (ZP8396). It is investigational and available only in trials. Talk to a clinician you trust, especially if you are pregnant, have diabetes, or a history of pancreatitis or gallbladder disease. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).