ABBV-295 / Gubra, AbbVie - LARVOL DELTA

Phase 1 multiple ascending dose study of ABBV-295, a long-acting amylin analog for the treatment of obesity (EASD 2026) - P1 | "ABBV-295 was well tolerated when dose-escalated to 14 mg across weekly and every-other-week dosing intervals and to 8 mg with once-monthly dosing, with all regimens resulting in meaningful weight loss. The half-life of ABBV-295 was approximately 11 days, which may support extended dosing intervals beyond weekly dosing. Further safety and efficacy of ABBV-295 will be assessed in future phase 2 studies."

First-in-human • Late-breaking abstract • P1 data • Metabolic Disorders • Obesity

Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Adverse events • Trial completion • Genetic Disorders • Obesity

Gubra H1 2026 slides: pipeline advances as CRO returns to profit (Investing.com) - "...ABBV-295, with Phase 2 initiation expected in Q3 2026."

Trial status • Obesity

A Study to Assess Adverse Events, Tolerability, and Pharmacokinetics of Subcutaneous Injections of ABBV-295 in Healthy Adult Japanese Participants With Overweight or Obesity. (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Genetic Disorders • Obesity

A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: AbbVie | N=48 ➔ 80 | Trial completion date: Oct 2026 ➔ Mar 2027 | Trial primary completion date: Oct 2026 ➔ Mar 2027

Adverse events • Enrollment change • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities (clinicaltrials.gov) - P2 | N=360 | Not yet recruiting | Sponsor: AbbVie

New P2 trial • Genetic Disorders • Obesity

Amylin Analogs: The Next Major Class of Weight Loss Therapy: A Review of Experimental Data and Early-Phase Clinical Trials. (PubMed, Diabetes Obes Metab) - "Amylin-based therapies represent a promising addition to the evolving treatment landscape of obesity. Their emerging efficacy as both standalone and combination therapies supports a multi pathway approach to addressing the biological complexity and heterogeneity of the disease."

Journal • Genetic Disorders • Obesity

A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: AbbVie | N=96 ➔ 48

Adverse events • Enrollment change • Genetic Disorders • Obesity

A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Genetic Disorders • Obesity

A Study to Assess Adverse Events, Tolerability, and Pharmacokinetics of Subcutaneous Injections of ABBV-295 in Healthy Adult Japanese Participants With Overweight or Obesity. (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AbbVie

Adverse events • New P1 trial • Genetic Disorders • Obesity

AbbVie Announces Positive Topline Results from a Phase 1 Multiple Ascending Dose Study of ABBV-295, a Long-Acting Amylin Analog, in Adults (PRNewswire) - "ABBV-295 demonstrated clinically meaningful, dose-dependent reductions in body weight from baseline, over a 12-13-week treatment period. In the ABBV-295 treated groups dose-dependent least-squares (LS) mean percentage change in body weight ranged from -7.75% to -9.79% at week 12 (for weekly dosing groups), to -7.86% to -9.73% at week 13 (for every other week dosing group and monthly dosing group after week 5), compared to -0.26% and -0.25% in the placebo group at week 12 and week 13, respectively....Full data from the study will be presented at a future scientific conference."

P1 data • Obesity

A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: AbbVie

Adverse events • New P1 trial • Genetic Disorders • Obesity

A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295 (clinicaltrials.gov) - P1 | N=76 | Completed | Sponsor: AbbVie | Recruiting ➔ Completed | N=124 ➔ 76

Enrollment change • First-in-human • Trial completion • Obesity

AbbVie Advances Obesity Pipeline With Completion of First-in-Human GUB014295 Trial (The Globe and Mail) - "This is a Phase 1, randomized trial in two parts. Volunteers are randomly placed into groups that receive either GUB014295 or placebo. Doses increase over time, first as single doses, then as repeated doses....The study has been completed and recently updated, with further details and future results to be made available on the ClinicalTrials.gov portal."

First-in-human • Trial completion • Obesity

AbbVie plans to build out its presence in obesity market (The Economic Times) - "AbbVie said on Wednesday it is seeking ‍to expand its presence in ​the fast-growing market for obesity treatments, leaning on ⁠the weight-loss drug it licensed last year from Danish biotech Gubra...Gubra's drug, GUBamy, mimics the hormone amylin and could be used as an alternative ‌to popular ‌GLP-1 drugs like Novo Nordisk's Wegovy and Eli Lilly's Zepbound to help people lose more ‌weight with fewer side effects."

Commercial • Obesity

A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: AbbVie

Adverse events • New P1 trial • Genetic Disorders • Obesity

A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295 (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: AbbVie | Trial primary completion date: Jan 2026 ➔ Apr 2026

First-in-human • Trial primary completion date • Obesity

MET-233 is a differentiated efficacious amylin analogue in preclinical studies, combinable with MET-097, an ultra-long acting GLP-1 receptor agonist (EASD 2025) - "Here, we profile MET-233, comparing it to other clinical-stage amylin analogues, cagrilintide, GUB014295, and petrelintide, and present data supporting the development of MET-233 and MET-097 as a combination therapeutic.Materials and Compounds were characterised in vitro via cAMP accumulation assays at human and rat calcitonin receptors (hCTR/rCTR) and human amylin receptor 3 (hAMYR3). In preclinical models, MET-233 is differentiated by its potency (efficacy at very low doses), PK durability, and combinability with MET-097, a fully-biased ULA GLP-1RA. Taken together, these properties suggest the potential for MET-233 to be combined with MET-097 as a differentiated, ULA treatment option for obesity and related diseases."

Preclinical • Metabolic Disorders • Obesity

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GUBamy, a Novel Long-Acting Amylin Analogue—A Single Ascending Dose Trial [WITHDRAWN] (ADA 2025) - No abstract available

Clinical • PK/PD data • Metabolic Disorders

AbbVie and Gubra Announce License Agreement to Develop an Amylin Analog for the Treatment of Obesity (PRNewswire) - "This collaboration between Gubra and AbbVie will accelerate the development of GUB014295 and build on the promising data shown in its Phase 1 single ascending dose (SAD) trial. Our team has been extremely impressed with AbbVie and their commitment to bring this important partnership to life. We look forward to working together throughout the development of the GUB014295 program.'...Under the terms of the agreement, AbbVie will lead development and commercialization activities of GUB014295 globally. Gubra will receive $350 million in total upfront payment and will be eligible to receive up to $1.875 billion in development, commercial and sales milestone payments with tiered royalties on global net sales."

Licensing / partnership • Obesity

A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295 (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Gubra A/S | Trial completion date: Dec 2024 ➔ Apr 2026 | Trial primary completion date: Jul 2024 ➔ Jan 2026 | N=48 ➔ 100

Enrollment change • Trial completion date • Trial primary completion date • Obesity

A First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295 (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Gubra A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Obesity