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NCT Number: NCT07832799

Comparing the Extent to Which Two Maridebart Cafraglutide Drug Products Are Made Available in the Body After a Single Subcutaneous Dose

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two maridebart cafraglutide drug products in participants living with overweight or obesity.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female participants, of any race, between 18 and 60 years of age (inclusive).
  • Females must not be pregnant or lactating.
  • Body mass index of ≥ 25.0 to < 40.0 kilograms per square meter (kg/m^2).
  • Have a stable body weight within 3 months before screening.

Exclusion criteria

  • History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
  • History of or active diabetes (regardless of type, except history of gestational diabetes), or hemoglobin A1c ≥ 6.5%.
  • History or evidence of endocrine disorder that can cause obesity.
  • History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase or amylase (> 2 x upper limit of normal [ULN]) at screening or check-in, or fasting serum triglyceride level of > 500 milligrams per deciliter (mg/dL) at screening.
  • Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ treated with curative intent, within the last 5 years.
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2.
  • History or current signs or symptoms of cardiovascular disease.
  • History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or its ingredients.
  • Estimated glomerular filtration rate ≤ 60 mL/min/1.73 m^2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (2021) at screening or check-in.
  • Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
  • Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in.
  • Current or prior use of all herbal medicines, vitamins, and supplements consumed by the participant within the 30 days prior to check-in.
  • Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives, whichever is longer, prior to check-in.
  • Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received maridebart cafraglutide.

Treatment and study plan

Maridebart cafraglutide

Drug

Maridebart cafraglutide will be administered via SC injection.

Other names: AMG 133, MariTide

Primary outcomes

  1. Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide

    Time frame: Up to Day 120

  2. Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide

    Time frame: Up to Day 120

  3. Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide

    Time frame: Up to Day 120

Secondary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events

    Time frame: Up to Day 120

  2. Number of Participants With Anti-Maridebart Cafraglutide Antibodies

    Time frame: Up to Day 120

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Maridebart Cafraglutide (AMG 133) Drug Products in Participants Living With Overweight or Obesity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

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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