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NCT Number: NCT06858878

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

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cedic Centro de Investigacion Clinica, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Body mass index ≥ 27 kg/m^2.
  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
  • Diagnosis of T2DM.

Exclusion criteria

  • Type 1 diabetes mellitus.
  • Self-reported change in body weight > 5 kg within 90 days before screening.
  • Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
  • Obesity induced by other endocrinologic disorders.
  • Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
  • History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
  • History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
  • Lifetime history of suicide attempt.

Treatment and study plan

Maridebart cafraglutide

Drug

Maridebart cafraglutide will be adminstered SC.

Other names: AMG 133, MariTide

Placebo

Drug

Placebo will be adminstered SC.

Primary outcomes

  1. Percent Change from Baseline in Body Weight at Week 72

    Time frame: Baseline and Week 72

Secondary outcomes

  1. Change from Baseline in Waist Circumference at Week 72

    Time frame: Baseline and Week 72

  2. Participant achieving ≥ 5% reduction in body weight from baseline at week 72

    Time frame: Baseline and Week 72

  3. Participant achieving ≥ 10% reduction in body weight from baseline at week 72

    Time frame: Baseline and Week 72

  4. Participant achieving ≥ 15% reduction in body weight from baseline at week 72

    Time frame: Baseline and Week 72

  5. Change from Baseline in Systolic Blood Pressure (SBP) at Week 72

    Time frame: Baseline and Week 72

  6. Percent Change from Baseline in Fasting Triglycerides at Week 72

    Time frame: Baseline and Week 72

  7. Change from Baseline in Fasting Plasma Glucose at Week 72

    Time frame: Baseline and Week 72

  8. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72

    Time frame: Baseline and Week 72

  9. Participant achieving HbA1c < 7% at week 72

    Time frame: Week 72

  10. 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

    Time frame: Baseline and Week 72

  11. Change from Baseline in Body Weight at Week 72

    Time frame: Baseline and Week 72

  12. Participant achieving ≥ 20% reduction in body weight from baseline at week 72

    Time frame: Baseline and Week 72

  13. Change from Baseline in Body Mass Index (BMI) at Week 72

    Time frame: Baseline and Week 72

  14. Participant achieving HbA1c ≤ 6.5% at week 72

    Time frame: Week 72

  15. Participant achieving HbA1c < 5.7%, at week 72

    Time frame: Week 72

  16. Percent Change from Baseline in Fasting Insulin at Week 72

    Time frame: Baseline and Week 72

  17. Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72

    Time frame: Baseline and Week 72

  18. Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72

    Time frame: Baseline and Week 72

  19. Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol

    Time frame: Baseline and Week 72

  20. Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C)

    Time frame: Baseline and Week 72

  21. Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline and Week 72

  22. Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C)

    Time frame: Baseline and Week 72

  23. Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline and Week 72

  24. Change from Baseline in Diastolic Blood Pressure DBP at Week 72

    Time frame: Baseline and Week 72

  25. Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72

    Time frame: Baseline and Week 72

  26. Number of Participants who Experienced Treatment-emergent Adverse Events

    Time frame: Up to Week 84

  27. Number of Participants who Experienced Serious Adverse Events

    Time frame: Up to Week 84

  28. Plasma Concentration of Maridebart Cafraglutide at Week 72

    Time frame: Week 72

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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)

Acronym: MARITIME-2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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