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

Amgen

Status and phase: Enrolling; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Maridebart Cafraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07226778

20230259

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Male or female, of any race, between 18 and 60 years of age, inclusive.

   a. Females must not be pregnant or lactating.

2. Body mass index between ≥25.0 and <40.0 kg/m^2.

Exclusion Criteria

1. 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 study evaluation, procedures, or completion.
2. 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).
3. History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity.
4. 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.
5. Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years.
6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
7. 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.
8. History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in.
9. History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or their ingredients.
10. Estimated glomerular filtration rate ≤60 mL/min/1.73 m^2, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation at screening or check-in.
11. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
12. Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in.
13. 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.
14. 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.
15. Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received the investigational product.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Maridebart Cafraglutide SC Presentation 1

Experimental group

Description:

Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 1.

Treatment:

Drug: Maridebart Cafraglutide

Maridebart Cafraglutide SC Presentation 2

Active Comparator group

Description:

Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 2.

Treatment:

Drug: Maridebart Cafraglutide