Breaking
Sunday, June 7, 2026
Share
High impact News 🇺🇸 FDA obesity

Companies: Amgen

Drugs: MariTide, maridebart cafraglutide

AMGN

AnalystsStrategyBd Teams

MariTide Phase 2 obesity data show up to 20% weight loss at one year

100% citation coverage1 peer-reviewed sources

Amgen’s MariTide phase 2 obesity data showed up to 20% average weight loss at 52 weeks in participants without type 2 diabetes. The trial also reported up to 17% average weight loss in participants with type 2 diabetes, with placebo results provided in the published data.

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

Intelligence Snapshot

Impact Score 80/100 High significance
Regulatory Impact 60/100 Moderate agency relevance
Market Impact 60/100 Moderate commercial pull
Clinical Relevance 74/100 Moderate clinical weight
Evidence Strength 87/100 High source quality
Confidence Score 85/100 High certainty
Reading Time 5 min Executive read
Relevant for Competitive Intelligence Corporate Strategy Pharma BD Regulatory Affairs Investors

Executive Summary

MariTide achieved up to ~20% average weight loss at 52 weeks in people with obesity without Type 2 diabetes , compared with 2.6% in placebo.

Key Insights

  1. In the obesity-with-Type 2 diabetes cohort, MariTide showed up to ~17% average weight…

    In the obesity-with-Type 2 diabetes cohort, MariTide showed up to ~17% average weight loss versus 1.4% placebo.

  2. MariTide is dosed monthly or less frequently .
  3. Amgen is running Phase 3 trials in obstructive sleep apnea , cardiovascular outcomes, and…

    Amgen is running Phase 3 trials in obstructive sleep apnea , cardiovascular outcomes, and heart failure with preserved or mildly reduced ejection fraction.

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 achieved up to ~20% average weight loss at 52 weeks in people with obesity without Type 2 diabetes , compared with 2.6% in placebo.

Key Questions

  • What weight loss did MariTide show in the Phase 2 trial?
  • What is once-monthly maridebart cafraglutide for the treatment of obesity?
  • What Phase 3 trials is Amgen running with MariTide?
  • What was the placebo weight loss in the Phase 2 trial?

Executive Scorecard

Heuristic scores · directional, not investment advice
Regulatory Readiness 60
Commercial Opportunity 60
Competitive Threat 82
Clinical Significance 64
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
Unlock full calendar →

Amgen pipeline snapshot

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

View public profile →
Contents10 sections

MariTide Phase 2 obesity data show up to 20% weight loss at one year

Amgen's MariTide phase 2 obesity data showed up to 20% average weight loss at 52 weeks in participants without type 2 diabetes. The trial also reported up to 17% average weight loss in participants with type 2 diabetes, with placebo results provided in the published data.

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

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 Placebo Control

The Phase 2 trial of once-monthly maridebart cafraglutide reported up to approximately 20% average weight loss in participants with obesity but without Type 2 diabetes. Placebo-treated participants in that same cohort experienced 2.6% weight loss.

In the subgroup with both obesity and Type 2 diabetes, MariTide demonstrated up to approximately 17% average weight loss. The trial included placebo controls in both arms, establishing a clear separation between active drug and control.

MariTide achieved this weight reduction at 52 weeks without hitting a plateau, suggesting continued efficacy through the trial's primary endpoint.

IntelligenceMarket Signals

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

Dosing and Clinical Development Pipeline

MariTide is a monthly or less frequently dosed obesity treatment. Amgen's Phase 3 development strategy extends beyond obesity. The company is recruiting for a Phase 3 trial of maridebart cafraglutide in obstructive sleep apnea in patients not on positive airway pressure therapy and a Phase 3 trial in obstructive sleep apnea patients already on PAP therapy. The company is also evaluating the drug in a Phase 3 cardiovascular outcomes trial in participants with atherosclerotic cardiovascular disease and overweight or obesity and a Phase 3 trial in heart failure with preserved or mildly reduced ejection fraction and obesity.

Amgen is also planning a Phase 3 switch trial comparing maridebart cafraglutide to GLP-1 receptor agonists in adults with obesity or overweight, and recruiting for a Phase 2 trial in elevated liver fat and obesity or overweight.

IntelligenceStrategic Takeaways

MariTide achieved up to ~20% average weight loss at 52 weeks in people with obesity without Type 2 diabetes , compared with 2.6% in placebo. In the obesity-with-Type 2 diabetes cohort, MariTide showed up to ~17% average weight loss versus 1.4% placebo. MariTide is dosed monthly or less frequently .

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 weight loss did MariTide show in the Phase 2 trial?

MariTide demonstrated up to approximately 20% average weight loss at 52 weeks in participants with obesity without Type 2 diabetes, and up to approximately 17% average weight loss in participants with obesity and Type 2 diabetes.

What is once-monthly maridebart cafraglutide for the treatment of obesity?

Once-monthly maridebart cafraglutide is the investigational name for MariTide, evaluated in a Phase 2 trial that reported substantial weight reductions in participants with obesity with or without Type 2 diabetes. MariTide is dosed monthly or less frequently.

What Phase 3 trials is Amgen running with MariTide?

Amgen is conducting multiple Phase 3 programs. One Phase 3 trial is evaluating maridebart cafraglutide in obstructive sleep apnea in patients not on positive airway pressure therapy, while another is examining cardiovascular outcomes in participants with atherosclerotic cardiovascular disease and overweight or obesity. A third Phase 3 trial is testing the drug in heart failure with preserved or mildly reduced ejection fraction and obesity. Additionally, Amgen is recruiting for a Phase 3 trial in obstructive sleep apnea patients already on PAP therapy.

What was the placebo weight loss in the Phase 2 trial?

In the obesity-without-Type 2 diabetes cohort, placebo-treated participants experienced 2.6% average weight loss. The trial included placebo controls to establish the drug's efficacy relative to standard care.

Related profiles

Related coverage

Continue Exploring

Jump into the entities behind this story.

Ask AI About obesity

Grounded in NovaPharmaNews intelligence. Pick a prompt to start.

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 obesity data show up to 20% weight loss at one year

Industry Reports & Whitepapers

Browse all whitepapers →