Amgen Expands Sleep Apnea Pipeline With Phase 3 Trial of Maridebart Cafraglutide

Amgen Inc (AMGN) announced an update on their ongoing clinical study.

Amgen Advances Phase 3 Sleep Apnea Drug in Overweight Adults

Amgen is running a Phase 3 study called “A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2).” The goal is to see if its drug maridebart cafraglutide can safely reduce obstructive sleep apnea in adults who are overweight or obese and are not using positive airway pressure machines, a group with high unmet medical need.

The treatment being tested is maridebart cafraglutide, given as a subcutaneous injection. It is compared with a matching placebo injection. The drug is designed to help manage weight and improve sleep apnea symptoms, potentially offering a drug-based option for patients who cannot or will not use standard device therapy.

The study is interventional and randomized, meaning participants are assigned by chance to either maridebart cafraglutide or placebo. It uses a parallel design, so each group receives only one treatment throughout the study. The trial is double-blind, so neither the patients nor the investigators know who is on the active drug versus placebo. The main purpose is treatment, with a focus on whether the drug works and is safe over 52 weeks.

The trial is currently recruiting. The study was first submitted in November 2025, marking the formal launch of the program. The latest update on January 14, 2026, signals that the protocol and status have been recently reviewed and refreshed. Primary completion and overall completion dates are not yet posted but will be key future milestones that could drive data releases and market reaction.

For investors, this update reinforces Amgen’s push into metabolic and sleep-related conditions, areas that have drawn strong market interest since the success of GLP-1–based obesity drugs. A positive readout could open a new revenue stream in obstructive sleep apnea and support Amgen’s growth narrative beyond its core oncology and inflammation franchises. It also positions the company as a potential competitor or partner in the broader obesity and sleep health space, where players like Eli Lilly and Novo Nordisk are already active. Ongoing recruitment and recent protocol activity suggest the program is on track, which may support sentiment among longer-term investors looking for pipeline-driven upside.

The study remains active and updated, with further details available on the ClinicalTrials portal.

To learn more about AMGN’s potential, visit the Amgen Inc drug pipeline page.