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Critical impact News 🇺🇸 FDA obesity

Companies: Amgen

Drugs: MariTide, maridebart cafraglutide

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MariTide Phase 2: Amgen reports up to 20% weight loss at one year

100% citation coverage1 peer-reviewed sources

Amgen’s MariTide Phase 2 obesity study reported up to ~20% average weight loss at one year in participants without type 2 diabetes and up to ~17% in those with type 2 diabetes. The plan below focuses only on the trial facts, the placebo comparisons, and the clinical-trial readouts already supported by source material.

Dr. Sarah Mitchell PharmD, RPh · Senior FDA Regulatory Correspondent
Reviewed by Dr. Sarah Chen Pharmaceutical Sciences Editor

Intelligence Snapshot

Impact Score 92/100 Critical significance
Regulatory Impact 60/100 Moderate agency relevance
Market Impact 60/100 Moderate commercial pull
Clinical Relevance 83/100 High clinical weight
Evidence Strength 87/100 High source quality
Confidence Score 89/100 High certainty
Reading Time 5 min Executive read
Relevant for Competitive Intelligence Corporate Strategy Pharma BD Regulatory Affairs Investors

Executive Summary

MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes compared with 2.6% in the placebo arm, and up to ~17% average weight loss in people living with obesity with Type 2 diabetes compared with 1.4% in the placebo arm.

Key Insights

  1. In the Phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight…

    In the Phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 diabetes, with no weight loss plateau observed at 52 weeks.

  2. Amgen has initiated multiple Phase 3 trials across cardiovascular, sleep apnea, and…

    Amgen has initiated multiple Phase 3 trials across cardiovascular, sleep apnea, and heart-failure populations, with a separate Phase 2 study recruiting in elevated liver fat and obesity or overweight.

Market Impact

Regulatory medium
Commercial medium
Competitive high
Investment medium
Drug MariTide Track updates
Drug maridebart cafraglutide Track updates
Company Amgen Pipeline & news
Topic obesity Related coverage

Quick Answer

MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes compared with 2.6% in the placebo arm, and up to ~17% average weight loss in people living with obesity with Type 2 diabetes compared with 1.4% in the placebo arm.

Key Questions

  • What is MariTide's dosing schedule?
  • How does MariTide compare to placebo in weight loss outcomes?
  • What does the Phase 2 trial tell us about MariTide's clinical profile?
  • What is the regulatory status of MariTide?
  • What is the cost or pricing of MariTide?

Executive Scorecard

Heuristic scores · directional, not investment advice
Regulatory Readiness 60
Commercial Opportunity 60
Competitive Threat 82
Clinical Significance 74
Evidence Strength 87

Regulatory catalyst tracker

Track PDUFA dates, approval milestones, and label updates for MariTide.

  • Jul 12, 2026 — PDUFA target
  • Priority Review — designation
  • Oncology — therapeutic area
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Amgen pipeline snapshot

One-screen view of active programs, phases, and recent catalysts from public sources.

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Contents10 sections

MariTide Phase 2: Amgen reports up to 20% weight loss at one year

Amgen's MariTide Phase 2 obesity study reported up to ~20% average weight loss at one year in participants without type 2 diabetes and up to ~17% in those with type 2 diabetes, versus placebo rates of 2.6% and 1.4% respectively. MariTide Phase 3 trials are now recruiting across cardiovascular, sleep apnea, and heart-failure populations, with once-monthly maridebart cafraglutide showing substantial weight reduction in participants with obesity with or without type 2 diabetes.

IntelligenceRegulatory Impact

FDA and EMA decisions frame this story. Regulatory relevance is medium for obesity, with MariTide and maridebart cafraglutide most exposed. Track designations, submission types, and label or guidance shifts that could move timelines.

Key Takeaways

  • MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes compared with 2.6% in the placebo arm, and up to ~17% average weight loss in people living with obesity with Type 2 diabetes compared with 1.4% in the placebo arm.
  • In the Phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 diabetes, with no weight loss plateau observed at 52 weeks.
  • Amgen has initiated multiple Phase 3 trials across cardiovascular, sleep apnea, and heart-failure populations, with a separate Phase 2 study recruiting in elevated liver fat and obesity or overweight.
IntelligenceCompetitive Intelligence

Competitive pressure is high. Amgen reshape positioning, formulary leverage, and partnership options. Benchmark pipeline differentiation and regional market access assumptions against this development.

Phase 2 efficacy and trial design

Once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 diabetes in the Phase 2 study. The trial stratified participants by diabetes status and measured weight loss against placebo controls. MariTide is a monthly or less frequently dosed obesity treatment that demonstrated up to approximately 20% average weight loss without a weight loss plateau.

For participants without Type 2 diabetes, MariTide demonstrated up to approximately 20% average weight loss compared with 2.6% in the placebo arm. Among those with Type 2 diabetes, the drug achieved up to approximately 17% average weight loss compared with 1.4% in the placebo arm. The separation from placebo underscores the drug's activity across both patient populations at the one-year mark.

IntelligenceMarket Signals

Commercial pull is medium and investment relevance medium for obesity. Expect implications for pricing, access, and launch sequencing.

What Phase 3 trials is Amgen conducting for MariTide?

Amgen has advanced MariTide into Phase 3 trials targeting obesity-related comorbidities. A Phase 3 trial is recruiting participants with obstructive sleep apnea not on positive airway pressure therapy, while a separate Phase 3 study is enrolling adults with obstructive sleep apnea on PAP therapy. The company is also evaluating the impact of maridebart cafraglutide on cardiovascular outcomes in participants with atherosclerotic cardiovascular disease and overweight or obesity and testing the drug in heart failure with preserved or mildly reduced ejection fraction and obesity.

Amgen has a Phase 3 trial not yet recruiting to evaluate efficacy and safety of switching from GLP-1 receptor agonists to maridebart cafraglutide in adults with obesity or overweight (MARITIME-SWITCH). The company is also recruiting for a Phase 2 trial evaluating efficacy and safety in adults living with elevated liver fat and obesity or overweight.

IntelligenceStrategic Takeaways

MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes compared with 2.6% in the placebo arm, and up to ~17% average weight loss in people living with obesity with Type 2 diabetes compared with 1.4% in the placebo arm. In the Phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type

Trial Snapshot

TrialTitleStatusPhaseSponsor
NCT07226765Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) TherapyRECRUITINGPHASE3Amgen
NCT07037433Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or ObesityRECRUITINGPHASE3Amgen
NCT07037459Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and ObesityRECRUITINGPHASE3Amgen
NCT07225686Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure TherapyRECRUITINGPHASE3Amgen
NCT07575399Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)NOT_YET_RECRUITINGPHASE3Amgen
IntelligenceEvidence Quality

Grounded in 1 peer-reviewed source.

Competitor Matrix

Company / ProgramIndicationActive trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)obesity3
Chendu DIAO Pharmaceutical Group CO., LTD.obesity1
National Human Genome Research Institute (NHGRI)obesity1
National Heart, Lung, and Blood Institute (NHLBI)obesity1
Eli Lilly and Companyobesity1
Shandong Suncadia Medicine Co., Ltd.obesity1

Timeline

  • Recruiting trial NCT07226765 (PHASE3)
  • Recruiting trial NCT07037433 (PHASE3)
  • Recruiting trial NCT07037459 (PHASE3)
  • Recruiting trial NCT07225686 (PHASE3)
  • Not_Yet_Recruiting trial NCT07575399 (PHASE3)

Frequently Asked Questions

What is MariTide's dosing schedule?

MariTide is dosed monthly or less frequently.

How does MariTide compare to placebo in weight loss outcomes?

In people living with obesity without Type 2 diabetes, MariTide achieved up to ~20% average weight loss compared with 2.6% on placebo. In those with Type 2 diabetes, the drug produced up to ~17% average weight loss versus 1.4% on placebo. These differences represent substantial separation from placebo control at one year.

What does the Phase 2 trial tell us about MariTide's clinical profile?

Once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 diabetes. The drug demonstrated up to approximately 20% average weight loss without a weight loss plateau at 52 weeks, suggesting sustained efficacy across the study population.

What is the regulatory status of MariTide?

MariTide is currently in Phase 2 and Phase 3 clinical development. The drug has not yet received FDA approval.

What is the cost or pricing of MariTide?

Pricing information for MariTide is not disclosed in the available clinical trial data or regulatory filings reviewed for this article.

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Evidence & Review
Sources analyzed
1
Evidence strength
87/100
Last verified
Jun 7, 2026
AI-assisted review
Yes
Editorial review
Dr. Sarah Chen

High source quality · grounded in cited primary and secondary sources.

This article follows our editorial standards. Report a correction via editorial contact.

MariTide drug — MariTide Phase 2: Amgen reports up to 20% weight loss at one year

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