Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06858839

Evaluation of Maridebart Cafraglutide in Adult Participants Without 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.

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases 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

Loading trial locations.

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 ≥ 30 kg/m2 or ≥27 kg/m² to < 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Exclusion criteria

  • Type 1 or Typ2 diabetes mellitus.
  • Obesity induced by other endocrinologic disorders.
  • Self-reported change in body weight > 5 kg within 90 days before screening.
  • 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 administered SC.

Other names: AMG 133, MariTide

Placebo

Drug

Placebo will be administered 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: Week 72

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

    Time frame: Week 72

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

    Time frame: Week 72

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

    Time frame: Week 72

  6. Change From Baseline in Systolic Blood Pressure (SBP) at Week 72

    Time frame: Baseline and Week 72

  7. Percent Change From Baseline in Fasting Triglycerides at Week 72

    Time frame: Baseline and Week 72

  8. Change From Baseline in Fasting Glucose at Week 72

    Time frame: Baseline and Week 72

  9. 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

    The IWQOL-Lite-CT is a 20-item questionnaire designed to assess the impact of weight on quality of life in clinical trials. Items are scored on a 5-point Likert scale, with raw scores transformed to a 0-100 scale, where higher scores indicate better quality of life and less weight-related impact.

  10. Change From Baseline in Body Weight at Week 72

    Time frame: Baseline and Week 72

  11. Change From Baseline in Body Mass Index (BMI) at Week 72

    Time frame: Baseline and Week 72

  12. Change From Baseline in Hemoglobin A1c at Week 72

    Time frame: Baseline and Week 72

  13. Percent Change From Baseline in Fasting Insulin at Week 72

    Time frame: Baseline and Week 72

  14. Change From Baseline in Glycemic Status at Week 72

    Time frame: Baseline and Week 72

  15. Percent Change From Baseline in Fasting Lipid Parameters at Week 72

    Time frame: Baseline and Week 72

    Lipid parameters include: total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and high-density lipoprotein cholesterol (HDL-C).

  16. Change From Baseline in Diastolic Blood Pressure (DBP) 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 Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72

    Time frame: Baseline and Week 72

    The SF-36v2 Acute Physical Function domain score measures an individual's ability to perform daily physical activities, such as walking and climbing stairs, over the past week. It includes 10 items scored on a 3-point Likert scale, with raw scores transformed to a 0-100 scale. Higher scores indicate better physical functioning and fewer limitations due to physical health.

  19. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 88 weeks

  20. 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 Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Acronym: MARITIME-1

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2025
Registry last updated
Oct 20, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.