Petrelintide

What it is

Petrelintide is a long-acting synthetic amylin analog. FDA maps it to ZP8396, ZP-8396, and UNII D78KBY7BRU. RO7895515 is a context-specific code in one registered Roche combination study—not a generic name for every amylin product.

The candidate name and amylin-analog description do not authenticate sequence, concentration, purity, sterility, stability, excipients, or delivery system. Trial formulations do not establish the identity of another product or another amylin analog.

Why people care

Interest centers on amylin-pathway weight-management development, the 42-week sponsor-reported ZUPREME 1 result, and a planned phase 3 program. The evidence requires clear distinctions between peer-reviewed phase 1 data, a sponsor conference poster, registered trial status, and product identity.

What humans actually show

Petrelintide is an investigational long-acting amylin analog also identified as ZP8396. Published phase 1 studies and a sponsor conference report from a completed phase 2 study provide human findings, while phase 3 is planned, but the record does not establish FDA approval, peer-reviewed confirmation of the phase 2 result, long-term benefit, combination safety, or another product's identity.

• randomized human — Healthy participants and adults with overweight or obesity in two phase 1 studies with single- and multiple-ascending components; Route: Subcutaneous study formulation; Outcome: Safety, tolerability, pharmacokinetics, and body-weight change through 16 weeks: In a 16-week multiple-dose component, the largest reported mean body-weight change was -8.6% versus -1.7% with placebo. No serious or severe treatment-emergent adverse events were reported; gastrointestinal events were common and mostly mild, and one participant discontinued because of gastrointestinal events. The seam: Phase 1, small groups, and 16 weeks; Sponsor funded; Cannot characterize uncommon, delayed, comparative, or post-treatment effects; Does not establish approval, long-term clinical benefit, or another product's identity.
• randomized human — Adults with overweight or obesity in the completed ZUPREME 1 phase 2 trial; registry enrollment 493 and sponsor-poster full-analysis set 485; Route: Subcutaneous study formulation; Outcome: Body-weight change and pooled safety measures through 42 weeks: The sponsor ADA 2026 poster reports mean body-weight changes from -8.7% to -10.7% across petrelintide groups versus -1.7% with placebo. It reports pooled treatment-emergent adverse events in 70.8% versus 69.1%, serious events in 3.5% versus 3.7%, and discontinuations due to adverse events in 4.5% versus 6.2%. The seam: Sponsor conference poster and data-on-file analysis, not a peer-reviewed full outcomes paper; Registry enrollment of 493 differs from the poster full-analysis set of 485 and requires reviewer reconciliation; Pooled safety percentages can obscure group-specific patterns; ClinicalTrials.gov had no posted results in the reviewed record; Does not establish long-term outcomes, maintenance, uncommon risks, approval, or comparative clinical benefit.
• other human — 221 adults with overweight or obesity and type 2 diabetes in ZUPREME 2; Route: Subcutaneous study formulation; Outcome: Registered phase 2 efficacy and safety outcomes: The study was active, not recruiting, with no posted results in the July 30 review. The seam: Registry information only; No efficacy or safety result can be inferred from registration; Does not establish approval or a type 2 diabetes conclusion.

Mechanistic and nonhuman evidence

• mechanistic — Peptide chemistry and in-vitro assay systems; Route: Laboratory studies; Outcome: Design, potency, stability, and amylin-receptor-related characterization: The original development paper reported selection of a potent, stable, long-acting human amylin analog for clinical development. The seam: Chemistry and assay evidence; Does not establish human efficacy, clinical superiority, safety, or product equivalence.
• animal — Nonhuman pharmacokinetic and metabolic models; Route: Experimental administration in nonhuman models; Outcome: Pharmacokinetics, food intake, and body weight: The development paper reported pharmacokinetic and food-intake/body-weight findings supporting clinical candidate selection. The seam: Animal evidence; Cannot establish human clinical benefit, comparative superiority, or long-term human safety.

FDA and U.S. status

An exact-active-ingredient Drugs@FDA API search returned no matching petrelintide application, and the name did not appear on FDA's 2026 novel-drug approvals page in this dated review. ClinicalTrials.gov records exact-candidate phase 1 and phase 2 studies, while sponsor materials describe a phase 3 program as planned for the second half of 2026. A planned program is not a registered, recruiting, completed, or successful phase 3 trial.

Risks and warning limits

• human trial: Gastrointestinal events were common and mostly mild in the published phase 1 program; one participant discontinued because of gastrointestinal events, and no serious or severe treatment-emergent adverse events were reported.
• human trial: The ZUPREME 1 sponsor poster reports pooled adverse-event, serious-event, discontinuation, and selected gastrointestinal-event percentages, but its non-peer-reviewed status and analysis denominator must remain visible.
• not characterized: No FDA-approved petrelintide prescribing information was located, so candidate-specific contraindications, warnings, pregnancy provisions, interactions, and postmarketing findings are not available to reproduce.

What remains unknown

• Peer-reviewed full reporting of ZUPREME 1 and reconciliation of the registry-enrollment and poster-analysis denominators remain outstanding.
• Results of ZUPREME 2 in adults with type 2 diabetes were not posted in the reviewed record.
• Whether a phase 3 program will be registered, start, complete, and confirm efficacy, safety, maintenance, and clinical outcomes remains unknown.
• Long-term and uncommon adverse effects, outcomes after treatment ends, direct combination evidence, and comparative benefit and harm remain unresolved.

Product identity and quality limits

• Petrelintide, ZP8396, ZP-8396, and the context-specific RO7895515 code map to a defined development candidate but do not authenticate a finished product.
• The name or amylin-analog description does not establish sequence, concentration, purity, sterility, stability, excipients, or delivery system.
• Findings for petrelintide cannot be transferred to pramlintide, cagrilintide, eloralintide, native amylin, or an unidentified material.

What has been studied together

• Enicepatide (CT-388; RO7795068) — no direct evidence: NCT07589686 registers a phase 2 dose-finding study of petrelintide with enicepatide. It was not yet recruiting, had an estimated September 30, 2026 start, and had no results in this review. Registration does not establish benefit, absence of interaction, tolerability, or clinical clearance.
• Approved incretin medicines or other amylin analogs — no direct evidence: No controlled outcome evidence was identified in this pass for petrelintide combined with an approved incretin medicine or another amylin analog.

What people are hearing

These are claims this profile checks, not established conclusions.

• Claim under review: “Petrelintide is approved or already in phase 3.”
• Claim under review: “The full ZUPREME 1 phase 2 result is peer reviewed.”
• Claim under review: “Petrelintide is known to be safe and effective in combination with another metabolic candidate.”

Questions readers raise

• No reproducible community sample was collected for this profile.

The community-signal layer is not efficacy or safety evidence. Its current limits are:

• No reproducible community sample was collected for this research draft.
• Online product identity cannot be verified from a name or self-report.
• Concurrent medicines, behaviors, and clinical conditions would confound anecdotal outcomes.
• Anecdotes cannot establish efficacy, safety, approval, interaction safety, or product quality.

What would change this answer

• A peer-reviewed full ZUPREME 1 report with participant-flow and denominator reconciliation would materially change confidence in the phase 2 assessment.
• Completed, fully reported phase 3 studies with efficacy, safety, maintenance, and clinical outcomes would materially change the evidence assessment.
• FDA approval documentation and current prescribing information for a defined petrelintide product would change the regulatory and labeled-warning sections.
• Posted results or a peer-reviewed report from a direct combination study would change the narrow interaction boundary.

Sources and records

• WADA — 2026 Prohibited List

• FDA GSRS/UNII record for petrelintide — U.S. Food and Drug Administration
• Drugs@FDA exact-active-ingredient API search for petrelintide — U.S. Food and Drug Administration
• FDA novel-drug approvals for 2026 — U.S. Food and Drug Administration
• Petrelintide randomized phase 1 single- and multiple-ascending studies — Diabetes, Obesity and Metabolism
• Discovery and preclinical characterization of petrelintide — Journal of Medicinal Chemistry
• NCT05096598: first-in-human petrelintide study — ClinicalTrials.gov
• NCT05613387: multiple-dose petrelintide study — ClinicalTrials.gov
• NCT06662539: ZUPREME 1 phase 2 study — ClinicalTrials.gov
• NCT06926842: ZUPREME 2 phase 2 study — ClinicalTrials.gov
• NCT07589686: petrelintide and enicepatide phase 2 study — ClinicalTrials.gov
• ZUPREME 1 ADA 2026 sponsor conference poster and slides — Zealand Pharma
• Petrelintide development pipeline page — Zealand Pharma
• ClinicalTrials.gov intervention search for petrelintide or ZP8396 — ClinicalTrials.gov
• PubMed Title/Abstract search for petrelintide or ZP8396 — National Library of Medicine