MARITIME-2: MariTide Phase 3 trial (NCT06858878)
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)
Registry record checked
At a glance
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrolment
- 1,105
- actual
- Start
- 17 Mar 2025 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Sponsor
- Amgen
Design
Arms and doses
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Maridebart Cafraglutide High Dose | Experimental | Drug: Maridebart cafraglutide | Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks. |
| Maridebart Cafraglutide Medium Dose | Experimental | Drug: Maridebart cafraglutide | Participants will receive maridebart cafraglutide medium dose SC for 72 weeks. |
| Maridebart Cafraglutide Low Dose | Experimental | Drug: Maridebart cafraglutide | Participants will receive maridebart cafraglutide low dose SC for 72 weeks. |
| Placebo | Placebo comparator | Drug: Placebo | Participants will receive placebo SC for 72 weeks. |
Endpoints
Primary endpoint
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight at Week 72 | Baseline and Week 72 |
Endpoints
Key secondary endpoints
The first secondary outcomes listed on the registry record.
| Measure | Time frame |
|---|---|
| Change from Baseline in Waist Circumference at Week 72 | Baseline and Week 72 |
| Participant achieving ≥ 5% reduction in body weight from baseline at week 72 | Baseline and Week 72 |
| Participant achieving ≥ 10% reduction in body weight from baseline at week 72 | Baseline and Week 72 |
| Participant achieving ≥ 15% reduction in body weight from baseline at week 72 | Baseline and Week 72 |
| Change from Baseline in Systolic Blood Pressure (SBP) at Week 72 | Baseline and Week 72 |
| Percent Change from Baseline in Fasting Triglycerides at Week 72 | Baseline and Week 72 |
| Change from Baseline in Fasting Plasma Glucose at Week 72 | Baseline and Week 72 |
| Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 | Baseline and Week 72 |
| Participant achieving HbA1c < 7% at week 72 | Week 72 |
| Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 | Baseline and Week 72 |
| Change from Baseline in Body Weight at Week 72 | Baseline and Week 72 |
| Participant achieving ≥ 20% reduction in body weight from baseline at week 72 | Baseline and Week 72 |
Eligibility
Who could enrol
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Results
Results
No results posted on ClinicalTrials.gov as of 2 Oct 2026.
Sources
- 1A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)ClinicalTrials.gov (U.S. National Library of Medicine) · registry recordclinicaltrials.govAccessed 2 Oct 2026
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