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MARITIME-2NCT06858878

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

StatusActive, Not Recruiting
PhasePhase 3
SponsorAmgen
Primary completion (estimated)
Track this trial

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Record History

All 17 versions: 17 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jan 30, 2027 to Jan 21, 2027
    • Study completion date: Apr 25, 2027 to Apr 16, 2027
    v17
  2. Trial status: Recruiting to Active, Not Recruitingv16 Show 4 more changesShow less
    • Enrollment target: estimated 999 to confirmed 1105
    • Primary completion date: Jan 21, 2027 to Jan 30, 2027
    • Study completion date: Apr 16, 2027 to Apr 25, 2027
    • Site details revised at 187 of 187 sites
  3. Site details revised at 1 of 187 sitesv15
  4. Site details revised at 1 of 187 sitesv14
  5. Study sites: 185 to 187v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 184 to 185v12
  2. Study sites: 161 to 184v11
  3. Study sites: 83 to 161v10
  4. Study sites: 80 to 83v9
  5. Study sites: 74 to 80v8
  6. Study sites: 71 to 74v7
  7. Study sites: 55 to 71v6
  8. Study sites: 53 to 55v5
  9. Study sites: 32 to 53v4
  10. Study sites: 29 to 32v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 29
    • Eligibility criteria revised
    • Secondary endpoints revised (28)
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percent Change from Baseline in Body Weight at Week 72
Timeframe: Baseline and Week 72

Secondary (28)

Change from Baseline in Waist Circumference at Week 72
Participant achieving ≥ 5% reduction in body weight from baseline at week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72
Participant achieving ≥ 15% reduction in body weight from baseline at week 72
Change from Baseline in Systolic Blood Pressure (SBP) at Week 72
Show 23 moreShow less
Percent Change from Baseline in Fasting Triglycerides at Week 72
Change from Baseline in Fasting Plasma Glucose at Week 72
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
Participant achieving HbA1c < 7% at 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
Change from Baseline in Body Weight at Week 72
Participant achieving ≥ 20% reduction in body weight from baseline at week 72
Change from Baseline in Body Mass Index (BMI) at Week 72
Participant achieving HbA1c ≤ 6.5% at week 72
Participant achieving HbA1c < 5.7%, at week 72
Percent Change from Baseline in Fasting Insulin at Week 72
Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72
Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol
Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C)
Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C)
Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C)
Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C)
Change from Baseline in Diastolic Blood Pressure DBP at Week 72
Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72
Number of Participants who Experienced Treatment-emergent Adverse Events
Number of Participants who Experienced Serious Adverse Events
Plasma Concentration of Maridebart Cafraglutide at Week 72

Arms and interventions

Maridebart Cafraglutide High DoseExperimental

Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.

Maridebart Cafraglutide Medium DoseExperimental

Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.

Maridebart Cafraglutide Low DoseExperimental

Participants will receive maridebart cafraglutide low dose SC for 72 weeks.

PlaceboPlacebo comparator

Participants will receive placebo SC for 72 weeks.

Drugs: Maridebart cafraglutide, Placebo

Sites

187 sites in 13 countries

United States 59, Germany 20, Canada 19, Poland 12, South Korea 12, Czechia 11, Hungary 11, Japan 11, United Kingdom 11, Argentina 7, Italy 7, Bulgaria 6, Puerto Rico 1