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Amgen Advances Monthly Obesity Drug to Phase 3 After 20% Weight Loss in Mid-Stage Trial

Amgen plans to use lower starting doses with gradual escalation to improve tolerability ahead of expanded Phase 3 studies

An Amgen sign is seen at the company's headquarters in Thousand Oaks, California, U.S., November 6, 2019. REUTERS/Deena Beasley/File Photo
Amgen's headquarters in Thousand Oaks, Calif., in 2023.
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Overview

  • In its Phase 2 trial, monthly MariTide injections produced up to 20% weight loss in patients with obesity alone and up to 17% in those with type 2 diabetes, versus under 3% for placebo groups.
  • Trial results showed reductions of as much as 2.2 percentage points in hemoglobin A1c; participants also saw lower blood pressure, inflammation markers and cholesterol levels.
  • Gastrointestinal events such as nausea and vomiting were common but became less frequent when dosing began at lower levels with gradual escalation, prompting Amgen to revise its regimen.
  • MariTide’s design couples a GLP-1 receptor agonist with a GIP receptor antagonist on a monoclonal antibody backbone, enabling extended monthly dosing.
  • The upcoming 72-week Phase 3 trial will randomize participants to three dosing arms; additional studies are planned for patients with cardiovascular disease, heart failure or obstructive sleep apnea.