MariTide Phase 2 trial (NCT05669599)
A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
Registry record checked
At a glance
- Phase
- Phase 2
- Status
- Completed
- Enrolment
- 592
- actual
- Start
- 18 Jan 2023 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Sponsor
- Amgen
Design
Arms and doses
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort A: Maridebart Cafraglutide | Experimental | Biological: Maridebart Cafraglutide; Drug: Placebo | Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts. |
| Cohort A: Placebo | Placebo comparator | Biological: Maridebart Cafraglutide; Drug: Placebo | Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts . Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts. |
| Cohort B: Maridebart Cafraglutide | Experimental | Biological: Maridebart Cafraglutide; Drug: Placebo | Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts. |
| Cohort B: Placebo | Placebo comparator | Biological: Maridebart Cafraglutide; Drug: Placebo | Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts. |
Endpoints
Primary endpoint
| Measure | Time frame |
|---|---|
| Percent Change From Baseline to Week 52 in Body Weight | Baseline and Week 52 |
Endpoints
Key secondary endpoints
The first secondary outcomes listed on the registry record.
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 52 | Baseline and Week 52 |
| Percentage of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 52 | Baseline and Week 52 |
| Achievement of ≥ 15% Reduction in Body Weight From Baseline at Week 52 | Baseline and Week 52 |
| Achievement of ≥ 20% Reduction in Body Weight From Baseline at Week 52 | Baseline and Week 52 |
| Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c) | Baseline and Week 52 |
| Change from Baseline to Week 52 in Fasting Serum Insulin | Baseline and Week 52 |
| Change from Baseline to Week 52 in Fasting Plasma Glucose | Baseline and Week 52 |
| Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR) | Baseline and Week 52 |
| Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B) | Baseline and Week 52 |
| Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide | Up to Week 64 |
| Area Under the Concentration-time Curve (AUC) of maridebart cafraglutide | Up to Week 64 |
| Change from Baseline to Week 52 in Waist Circumference | Baseline and Week 52 |
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 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes MellitusClinicalTrials.gov (U.S. National Library of Medicine) · registry recordclinicaltrials.govAccessed 2 Oct 2026
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