ABBV-295 / Gubra, AbbVie - LARVOL DELTA

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GUBamy, a Novel Long-Acting Amylin Analogue—A Single Ascending Dose Trial (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

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