Fact CheckerSign in

NCT07832799Not yet recruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 22 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
340 (estimated)
First submitted
16 Sept 2026
Start date
12 Oct 2026
Primary completion date
23 Mar 2027
Lead sponsor
Amgen
Diseases
Obesity
NCT number
NCT07832799

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 340
  • From 12 Oct 2026 to the primary completion date, 23 Mar 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ treated with curative intent, within the last 5 years.
  • Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before 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  • Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received maridebart cafraglutide.

Other illness

  • 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 or evidence of endocrine disorder that can cause obesity.
  • 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.

Lab values

  • History of or active diabetes (regardless of type, except history of gestational diabetes), or hemoglobin A1c ≥ 6.5%.
  • 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.
  • 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.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.