Amylin2026-04-26

Amylin Competitive Intelligence: April 2026

Mar 1, 2026 – Apr 26, 2026

Five developments across the amylin receptor agonist landscape: petrelintide's Phase 2 ZUPREME-1 trial showing up to 10.7% weight loss with placebo-like GI tolerability; ABBV-295 Phase 1 MAD data confirming up to 9.79% weight reduction with no SAEs; a published in vitro characterization of cagrilintide's skeletal muscle mitochondrial profile; Structure Therapeutics announcing ACCG-2671 NHP combination data at ADA 2026; and the AbbVie/Gubra licensing deal that brought ABBV-295 to a large-cap commercial partner.

This report covers six developments across the amylin receptor agonist space tracked from March 1 through April 26, 2026: two distinct clinical trial data outputs for petrelintide (2 Phase 1 trial results and Phase 2 ZUPREME-1 topline data), Phase 1 multiple ascending dose (MAD) results for ABBV-295, an in vitro characterization of cagrilintide's skeletal muscle mitochondrial profile, an upcoming ADA 2026 conference presentation for the oral small molecule amylin receptor agonist ACCG-2671, and the licensing transaction that brought ABBV-295 to AbbVie. The covered events reflect increasing activity in a field with currently one approved amylin-based agent (pramlintide).

Executive Summary of Key Events

Trial Readouts

Petrelintide (Zealand Pharma / Roche), Phase 1 (Published April 22, 2026): Olsen et al. published the first two clinical trials of petrelintide in Diabetes, Obesity and Metabolism (2026; doi:10.1111/dom.70753). The Phase 1 SAD and MAD trials confirmed petrelintide's safety and tolerability across doses up to 9.0 mg once-weekly (no SAEs in either trial), a half-life of approximately 10 days supporting once-weekly subcutaneous dosing, and up to 8.6% body weight reduction at 16 weeks in the MAD Part 2 obesity cohort versus 1.7% with placebo. GI disorders were reported in approximately 50% of petrelintide- and placebo-treated participants across both parts of the MAD trial, with one treatment discontinuation in MAD Part 2.
Petrelintide (Zealand Pharma / Roche), Phase 2 ZUPREME-1 (March 5, 2026): On March 5, 2026, Roche announced positive topline results from ZUPREME-1 (NCT06662539), a 42-week, placebo-controlled, dose-finding Phase 2 trial in 493 participants with overweight or obesity (mean BMI 37 kg/m²). All five petrelintide arms met the primary endpoint at week 28. The maximally effective arm achieved 10.7% mean weight loss at week 42 versus 1.7% with placebo. Discontinuation due to adverse events was 4.8% for petrelintide versus 4.9% for placebo in the maximally effective arm; no vomiting was observed in that arm. Full data will be presented at a future medical congress.
ABBV-295 (AbbVie), Phase 1 MAD (March 9, 2026): On March 9, 2026, AbbVie reported positive topline results from the MAD part of its Phase 1 study (NCT06144684; n=76) of ABBV-295, a long-acting amylin analogue. Across weekly, every-other-week, and monthly dosing cohorts, least-squares mean body weight reductions ranged from −7.75% to −9.79% at weeks 12–13 versus −0.26% with placebo. No serious adverse events were reported; GI adverse events were predominantly mild and concentrated in the first six weeks of treatment.

Preclinical & Research

Cagrilintide (Old et al., University of Leicester / NIHR BRC), Published March 19, 2026: An in vitro study published in the Journal of Cachexia, Sarcopenia and Muscle (2026; doi:10.1002/jcsm.70254) compared the effects of semaglutide, tirzepatide, and cagrilintide on skeletal muscle mitochondrial function in C2C12 murine myotubes and primary human skeletal muscle cells. Cagrilintide induced transient reductions in ATP production and basal respiration at 48 h that resolved fully by five days, a pattern shared with semaglutide and distinct from tirzepatide, which produced delayed but sustained improvements in mitochondrial capacity. The study is the first published characterization of cagrilintide's in vitro mitochondrial profile.

Upcoming Conference Presentations

ACCG-2671 (Structure Therapeutics), ADA 2026 (April 27, 2026 announcement): On April 27, 2026, Structure Therapeutics announced two late-breaking poster presentations at the American Diabetes Association 86th Scientific Sessions (June 5–8, 2026, New Orleans). One poster (3061-LB, June 7) will present NHP combination data for ACCG-2671, an oral small molecule amylin receptor agonist, paired with aleniglipron (Structure's oral GLP-1RA), showing additive weight loss versus monotherapy. A second poster (3062-LB, June 7) will compare conditioned taste avoidance profiles across GLP-1 peptides, amylin peptides, and small molecule amylin receptor agonists.

BD / Licensing

ABBV-295 / GUB014295 (AbbVie / Gubra A/S), Transaction Date March 3, 2025: On March 3, 2025, AbbVie and Gubra A/S announced a licensing agreement under which AbbVie will lead global development and commercialization of GUB014295 (now ABBV-295), a long-acting amylin analogue. Gubra received $350 million upfront and is eligible for up to $1.875 billion in development, commercial, and sales milestone payments, plus tiered royalties. The transaction marked AbbVie's entry into the obesity field.

SAD — Single Ascending Dose, MAD — Multiple Ascending Dose, SAEs — Serious Adverse Events, GI — Gastrointestinal, BMI — Body Mass Index, NHP — Non-Human Primate, GLP-1RA — Glucagon-Like Peptide-1 Receptor Agonist, NIHR BRC — National Institute for Health Research Biomedical Research Centre, ADA — American Diabetes Association

Events Overview

Company	Asset	Mechanism	Program / Event	Category	Date
AbbVie / Gubra A/S	ABBV-295 (GUB014295)	Long-acting amylin analogue	Licensing agreement	BD / Licensing	March 3, 2025
University of Leicester / NIHR BRC	Cagrilintide	Amylin analogue	In vitro skeletal muscle mitochondrial study (Old et al., J Cachexia Sarcopenia Muscle)	Research Publication	March 19, 2026
Zealand Pharma / Roche	Petrelintide	Long-acting amylin analogue	ZUPREME-1 Phase 2 topline (NCT06662539)	Trial Readout	March 5, 2026
AbbVie	ABBV-295	Long-acting amylin analogue	Phase 1 MAD topline (NCT06144684)	Trial Readout	March 9, 2026
Zealand Pharma / Roche	Petrelintide	Long-acting amylin analogue (AMY1, AMY3 agonist)	Phase 1 SAD/MAD (Olsen et al., Diabetes, Obesity and Metabolism)	Trial Readout	April 22, 2026
Structure Therapeutics	ACCG-2671	Oral small molecule amylin receptor agonist	ADA 2026 late-breaking poster (3061-LB)	Conference Announcement	April 27, 2026

MAD — Multiple Ascending Dose, SAD — Single Ascending Dose, AMY1 — Amylin Receptor 1, AMY3 — Amylin Receptor 3, ADA — American Diabetes Association, NIHR BRC — National Institute for Health Research Biomedical Research Centre

Trial Readouts

2 drugs

Therapy: PetrelintideSponsor: Zealand Pharma / RocheMost Recent Readout: March 5, 2026

Olsen et al. published the first two clinical trials of petrelintide (Phase 1 SAD and MAD) in Diabetes, Obesity and Metabolism (April 22, 2026). Roche separately reported positive topline results from the 42-week Phase 2 ZUPREME-1 dose-finding trial in 493 participants with overweight or obesity (March 5, 2026).

Phase 1 SAD/MAD (Published April 22, 2026; Olsen et al.)

133 participants across two trials; MAD Part 2 in overweight/obesity cohort (mean BMI 29.9 kg/m²)
Safety: No SAEs in either trial; no dose reductions required; no anti-drug antibodies detected
GI tolerability (both MAD parts): GI disorders reported in ~50% of petrelintide- and placebo-treated participants across both parts of the MAD trial; one treatment discontinuation in MAD Part 2
PK: Terminal half-life ~10 days (absorption-independent); steady state after 5th weekly dose; SC bioavailability 77.4%
Efficacy at week 16 (MAD Part 2): 4.8% weight loss (2.4 mg), 8.6% (4.8 mg), 8.3% (9.0 mg) vs. 1.7% placebo; all placebo-adjusted differences significant (p ≤ 0.0002)

Phase 2 ZUPREME-1 (NCT06662539; Roche press release, March 5, 2026)

493 participants with overweight or obesity (mean BMI 37 kg/m²); 5 dose arms; 33 sites (US, Poland, Romania)
All 5 petrelintide arms met primary endpoint at week 28 vs. placebo
Efficacy at week 42 (max effective arm): 10.7% mean weight loss vs. 1.7% placebo; 98% of participants reached maintenance dose
Safety (max effective arm): AE discontinuation 4.8% petrelintide vs. 4.9% placebo; no vomiting; overall trial withdrawal 8.4% vs. 13.6% placebo
Full data (MRI body composition, 9-week follow-up) to be presented at future congress; ZUPREME-2 (T2D cohort) topline expected H2 2026

Drug Background

Petrelintide is a 37-amino acid, long-acting subcutaneous amylin analogue with potent agonistic activity at AMY1 and AMY3 amylin receptors and the calcitonin receptor. It is engineered for chemical and physical stability at neutral pH to support once-weekly SC dosing and potential co-formulation with other peptide therapeutics.

AMY1 — Amylin Receptor 1, AMY3 — Amylin Receptor 3, BMI — Body Mass Index, GI — Gastrointestinal, MAD — Multiple Ascending Dose, PK — Pharmacokinetics, SAD — Single Ascending Dose, SAEs — Serious Adverse Events, SC — Subcutaneous

Therapy: ABBV-295Sponsor: AbbViePhase 1 MAD Readout: March 9, 2026

AbbVie reported positive topline results from the multiple ascending dose (MAD) part of its Phase 1 study (NCT06144684) of ABBV-295, testing doses of 2–14 mg across weekly, every-other-week, and monthly dosing cohorts in 76 participants (press release, March 9, 2026).

Phase 1 MAD (NCT06144684; AbbVie press release, March 9, 2026)

76 participants (88.3% male); mean BMI < 30 kg/m²; doses 2–14 mg across weekly, every-other-week, and monthly cohorts
Efficacy at weeks 12–13: LS mean weight reduction ranged from -7.75% (weekly, Cohort 3) to -9.79% (weekly, Cohort 5a) vs. -0.26% placebo at week 12
Every-other-week cohort (5b): -9.73% at week 13; monthly cohort (6): -7.86% at week 13
Safety: No SAEs; GI adverse events predominantly mild, concentrated in first 6 weeks of treatment
AbbVie characterized results as supporting continued development as a potentially differentiated treatment for chronic weight management (per press release)

Drug Background

ABBV-295 (formerly GUB014295) is a long-acting subcutaneous amylin and calcitonin receptor agonist. It activates amylin and calcitonin receptors, with a non-incretin mechanism of action distinct from GLP-1 and GIP receptor agonists.

BMI — Body Mass Index, GI — Gastrointestinal, GIP — Glucose-Dependent Insulinotropic Polypeptide, SAEs — Serious Adverse Events

Preclinical & Research

1 drug

Therapy: CagrilintideSponsor: University of Leicester / NIHR Leicester BRC (independent academic study)Publication: March 19, 2026

Old et al. published the first in vitro characterization of cagrilintide's skeletal muscle mitochondrial profile, comparing its effects with semaglutide and tirzepatide in C2C12 murine myotubes and primary human skeletal muscle cells (Journal of Cachexia, Sarcopenia and Muscle, March 19, 2026). This is an independent academic study; not a Novo Nordisk-sponsored disclosure.

In Vitro Mitochondrial Study (Published March 19, 2026; Old et al., doi:10.1002/jcsm.70254)

Model: C2C12 murine myotubes + primary human skeletal muscle cells; Seahorse respirometry; healthy and PA-induced lipotoxic conditions; 10 nM and 400 nM doses
At 48 h (healthy C2C12 myotubes): Significant reductions in ATP production (cagril-low p = 0.02, cagril-high p = 0.002) and basal respiration (cagril-low p = 0.024, cagril-high p = 0.002); coupling efficiency unchanged (p > 0.05)
By 5 days: All effects fully resolved; mtDNA copy number stable throughout (no mitochondrial biogenesis disruption)
Primary human myotubes (48 h): Reductions in ATP production (p < 0.0001) and basal respiration (p = 0.0022) confirmed; resolved by 5 days
Vs. tirzepatide: Tirzepatide (dual GLP-1/GIP) produced sustained increases in maximal respiration and spare respiratory capacity by day 5; cagrilintide and semaglutide showed only transient suppression
Limitation: All findings from an in vitro model; in vivo validation required
Authors note further studies are warranted to assess combined GLP-1/amylin treatment effects

Drug Background

Cagrilintide is a long-acting amylin analogue that activates amylin receptors. It is in late-stage clinical development by Novo Nordisk as a monotherapy and as CagriSema (co-formulated with semaglutide 2.4 mg once-weekly).

GIP — Glucose-Dependent Insulinotropic Polypeptide, mtDNA — Mitochondrial DNA, PA — Palmitic Acid (lipotoxic challenge model)

Upcoming Conference Presentations

1 drug

Therapy: ACCG-2671Sponsor: Structure Therapeutics (NASDAQ: GPCR)Presentation Date: June 7, 2026

Structure Therapeutics announced two late-breaking poster presentations at ADA 2026 (June 5–8, 2026, New Orleans) featuring ACCG-2671, covering the first NHP combination data with aleniglipron and a conditioned taste avoidance comparison study (press release, April 27, 2026).

ADA 2026 Late-Breaking Posters (Press release, April 27, 2026)

Poster 3061-LB (June 7, 12:30–1:30 p.m. CT): First NHP combination data for ACCG-2671 + aleniglipron (oral GLP-1RA); additional weight loss vs. monotherapy reported; no efficacy figures disclosed in announcement
Poster 3062-LB (June 7, 12:30–1:30 p.m. CT): CTA comparison across GLP-1 peptides, amylin peptides, and small molecule amylin receptor agonists
Structure Therapeutics will also present ACCESS Phase 2b trial data for aleniglipron (oral presentation, June 5) and two additional aleniglipron posters
Note: No efficacy or safety figures for ACCG-2671 were disclosed in the April 27 announcement

Drug Background

ACCG-2671 is an investigational oral small molecule amylin receptor agonist in preclinical development at Structure Therapeutics. Unlike peptide-based amylin analogues, it is formulated for oral administration as a small molecule.

CTA — Conditioned Taste Avoidance, GLP-1RA — Glucagon-Like Peptide-1 Receptor Agonist, NHP — Non-Human Primate

BD / Licensing Activity

1 drug

Therapy: ABBV-295Sponsor: AbbVie / Gubra A/STransaction Date: March 3, 2025

AbbVie and Gubra A/S announced a licensing agreement under which AbbVie acquires global development and commercialization rights to GUB014295 (renamed ABBV-295 post-close), a long-acting amylin analogue discovered and advanced through Phase 1 SAD by Gubra (press release, March 3, 2025).

AbbVie / Gubra A/S License Agreement (Press release, March 3, 2025)

Upfront payment to Gubra: $350 million
Milestone potential: Up to $1.875 billion (development, commercial, and sales milestones)
Plus tiered royalties on global net sales
AbbVie leads all global development and commercialization
Asset status at announcement: Phase 1 SAD complete; Phase 1 MAD (NCT06144684) ongoing
The transaction marked AbbVie's entry into the obesity field (per press release)
Advisors: Morgan Stanley (financial, Gubra); Goodwin Procter / Plesner (legal, Gubra)

Drug Background

ABBV-295 (formerly GUB014295) is a long-acting subcutaneous amylin and calcitonin receptor agonist discovered by Gubra A/S, a Danish peptide drug discovery company. It activates amylin and calcitonin receptors, with a non-incretin mechanism of action distinct from GLP-1 and GIP receptor agonists.

GIP — Glucose-Dependent Insulinotropic Polypeptide, MAD — Multiple Ascending Dose, SAD — Single Ascending Dose

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Concluding Remarks

This monitoring period covered six events across the amylin receptor agonist space: Phase 1 SAD/MAD results and Phase 2 ZUPREME-1 topline data for petrelintide (Zealand Pharma / Roche); Phase 1 MAD topline results for ABBV-295 (AbbVie); an independent in vitro skeletal muscle mitochondrial characterization of cagrilintide; a poster announcement at ADA 2026 for ACCG-2671, an oral small molecule amylin receptor agonist; and the AbbVie / Gubra licensing agreement. As of the delivery date, three long-acting amylin analogues have published human clinical data and one oral small molecule programme has announced preclinical combination evidence in non-human primates.

Methodology

This report covers events in the amylin receptor agonist space tracked from March 1, 2026 through April 26, 2026. Events were identified through monitoring of peer-reviewed publications, company press releases, SEC filings, and investor communications from companies active in amylin-based drug development. The licensing agreement (AbbVie / Gubra) is dated March 3, 2025 and is included as foundational context for the ABBV-295 clinical programme. The ADA 2026 abstract announcement (Structure Therapeutics) covers an event occurring after the report delivery date; no efficacy data were disclosed in advance of the presentation.

References

[1] Olsen MB, Griffin J, Hövelmann U, et al. "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials." Diabetes, Obesity and Metabolism. 2026. Link

[2] Roche. "Roche announces positive Phase II results for petrelintide, an amylin analog developed for people living with overweight and obesity." Press release, March 5, 2026. Link

[3] AbbVie. "AbbVie Announces Positive Topline Results from a Phase 1 Multiple Ascending Dose Study of ABBV-295, a Long-Acting Amylin Analog, in Adults." Press release, March 9, 2026. Link

[4] Structure Therapeutics Inc. "Structure Therapeutics to Present Aleniglipron, Amylin and Combination Data at the American Diabetes Association 86th Scientific Sessions." Press release, April 27, 2026. Link

[5] AbbVie / Gubra A/S. "AbbVie and Gubra Announce License Agreement to Develop an Amylin Analog for the Treatment of Obesity." Press release, March 3, 2025. Link

[6] Old V, Davies M, Denniff M, et al. "Mitochondrial Adaptations in Skeletal Muscle Following Incretin-Based Therapies: In Vitro." Journal of Cachexia, Sarcopenia and Muscle. 2026;17:e70254. Link

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