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NCT07313761CompletedPhase 1

A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations

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

Source: ClinicalTrials.gov · Last updated 7 Aug 2026

Brief summary (registry, in English)

The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
349 (actual)
First submitted
19 Dec 2025
Start date
15 Dec 2025
Primary completion date
2 Jul 2026
Lead sponsor
Amgen
Diseases
Obesity
NCT number
NCT07313761

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 349
  • From 15 Dec 2025 to the primary completion date, 2 Jul 2026
  • 4 sites in 1 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

  • 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, or gastric inhibitory polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in.
  • Current or prior use of all herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, unless deemed acceptable by the investigator (or designee) and in consultation with the medical monitor, as appropriate.
  • 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  • Have previously completed or withdrawn from this trial or any other trial investigating AMG 133 or have previously received the investigational product.

Other illness

  • History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity.
  • Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years.
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
  • History or current signs or symptoms of cardiovascular disease (aside from controlled hypertension and controlled dyslipidemia), including but not limited to myocardial infarction, congenital heart disease, valvular heart disease, coronary revascularization, or angina.
  • History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in.
  • History of hypersensitivity, intolerance, or allergy to AMG 133 or related/similar compounds or their ingredients.
  • Estimated glomerular filtration rate ≤60 mL/min/1.73 m\^2, as calculated by the Chronic Kidney Disease Epidemiology (CKD EPI) equation at screening or check-in.

Lab values

  • History or evidence, at screening or check-in, 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 trial evaluation, procedures, or completion. Participants with clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) as assessed by the investigator (or designee) will be excluded.
  • History of or active diabetes (regardless of type, with the exception of a history of gestational diabetes) or hemoglobin A1C ≥6.5% (≥48 mmol/mol).
  • History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (\>2 x the upper limit of normal) at screening or a fasting serum triglyceride level of \>500 mg/dL at screening.

Who the study is looking for

  • Male or female, of any race, between 18 and 60 years of age, inclusive.
    • Females must not be pregnant or lactating.
  • Body mass index between 25.0 and \<40.0 kg/m\^2.
  • Have a stable body weight (\<5 kg self-reported change) within 3 months before screening, as assessed by the investigator (or designee) based on participant self-report.

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

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anaheim Clinical Trials
Coordinator of this site? Confirm its status
AnaheimUnited StatesUnknown status
Ohio Clinical Trials, Inc.
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
CenExel Collaborative Neuroscience Research, LLC Los Alamitos
Coordinator of this site? Confirm its status
Los AlamitosUnited StatesUnknown status
Clinical Pharmacology of Miami, LLC
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status

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