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Section 1 of 6Overview
Overview
Petrelintide is an investigational long-acting amylin analogue. Early development used Zealand Pharma’s code ZP8396; Roche lists RO7895515. PubChem CID 172915807 records formula C₁₈₅H₃₀₅N₄₉O₆₁ and MW 4192. Clinical use in trials has been once-weekly subcutaneous.
Zealand led early-phase work; Hoffmann-La Roche is lead sponsor on listed phase 3 studies, with Zealand as collaborator. No regulatory approval was identified as of the 2026-10-07 dossier cut.
Company materials emphasise chemical/physical stability at neutral pH (no fibrillation) to enable co-formulation. Treat that as a pipeline/design claim until independent analytical and clinical combination data are published.
Place in the amylin landscape
- Pramlintide — short-acting, FDA-approved diabetes adjunct.
- Cagrilintide / CagriSema — Novo long-acting amylin pathway ± semaglutide.
- Eloralintide — Lilly agent with a published AMY1R-selective narrative; petrelintide should be described as an amylin analogue, not as AMY1R-selective, unless a primary source measures that selectivity.
Section 2 of 6Clinical development (selected)
Clinical development (selected)
| NCT | Phase | Status (dossier cut) | Role |
|---|---|---|---|
| NCT05096598 (opens in a new tab) | 1 | Completed | SAD first-in-human (ZP8396) |
| NCT05613387 (opens in a new tab) | 1 | Completed | MAD 6 weeks + escalation to 16 weeks |
| NCT06662539 (opens in a new tab) | 2 | Completed | ZUPREME-1 (obesity/overweight without T2D; n=493) |
| NCT06926842 (opens in a new tab) | 2 | Completed | ZUPREME-2 (overweight/obesity + T2D; n=221) — topline pending in dossier |
| NCT07843498 (opens in a new tab) | 3 | Recruiting | Obesity/overweight without T2D (~3900) |
| NCT07843472 (opens in a new tab) | 3 | Recruiting | With established CVD (ZUPREME-5) |
| NCT07589686 | 2 | Not yet recruiting | Dose-finding combination with enicepatide (RO7795068) — verify identity vs CT-388 before equating codes |
Section 3 of 6Key human results
Key human results
Phase 1 — peer-reviewed (Brændholt Olsen et al., 2026; PMID 42017294)
SAD explored subcutaneous 0.04–2.4 mg (plus a 0.35 mg IV cohort). MAD part 1 used 0.6 and 1.2 mg for 6 weeks; part 2 escalated toward 2.4 / 4.8 / 9.0 mg over 16 weeks. Half-life was about 10 days with dose-proportional steady-state PK. Weight loss reached about −8.6% after 16 weeks in MAD part 2; GI events were mostly mild in the published abstract framing.
Phase 2 ZUPREME-1 — company topline (not peer-reviewed full text in the dossier search)
Roche’s 5 March 2026 media release stated that the primary endpoint (weight at week 28) was met in all five dose arms versus placebo (n=493; mean BMI 37). At week 42, mean weight loss was reported up to 10.7% (efficacy estimand) versus 1.7% placebo (p less than 0.001). The release also asserted favourable GI tolerability language, including zero vomiting and zero GI-related discontinuations in a “maximally effective” arm — company wording.
ZUPREME-1 figures are press topline
Until a peer-reviewed full paper (or congress abstract with full methods) is available, treat ZUPREME-1 percentages and tolerability claims as sponsor topline, not as established peer-reviewed effect sizes.
ZUPREME-2 and phase 3
ZUPREME-2 (NCT06926842) was marked completed (n=221) with topline expected later per company communication — no results in the dossier pass. Phase 3 obesity and cardiovascular-comorbidity trials were recruiting under Roche lead.
Combination pipeline
Roche/Zealand have described a planned phase 2 of petrelintide with CT-388 (dual GIP/GLP-1). CT.gov also lists petrelintide + enicepatide (RO7795068) (NCT07589686). Do not merge CT-388 and enicepatide into one asset without a primary source that equates them. No published combination efficacy was identified.
Section 4 of 6Claims vs evidence
Claims vs evidence
| Claim | Assessment |
|---|---|
| Zealand/Roche long-acting amylin analogue ZP8396 / RO7895515 | Supported |
| Phase 1 human PK/weight/safety | Supported (PMID 42017294) |
| ZUPREME-1 ~10.7% at week 42 | Topline only (Roche PR 2026-03-05) |
| Better tolerability than GLP-1 agonists | Unverified claim without head-to-head data |
| Co-formulation / CT-388 combination efficacy | Pipeline claim — no published combo efficacy in the dossier |
| Approved medicine | No |
Section 5 of 6Related pages
Section 6 of 6What this page intentionally omits
What this page intentionally omits
- Self-use doses, stacks, or reconstitution protocols
- Equating sponsor press toplines with peer-reviewed phase 2 proof
- Unverified identity merges between CT-388 and enicepatide