Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity

Recruiting at 2 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must not be taking: Corticosteroids, Antidepressants, Antipsychotics, others

Disqualifiers: Diabetes, Hypertension, Thyroid disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

110 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking most prescription and nonprescription drugs, herbal medicines, vitamins, and supplements before starting the study, unless approved by the study doctor. There is a specific period of 14 days or 5 half-lives (whichever is longer) for prescription and nonprescription drugs, and 30 days for herbal medicines, vitamins, and supplements before the first dose of the study drug.

What is the purpose of this trial?

This trial aims to test if AMG 133 is safe and can be tolerated by people with obesity.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

Inclusion Criteria

You have provided informed consent before any study-specific activities/procedures.

You must have a smartphone device with the capability of downloading apps or other digital tools required for this cohort.

Except for obesity, otherwise healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and ECGs on day -2 (cohorts 1-6, cohort 11-13) or day -1 (cohorts 7-10) and screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending doses of maridebart cafraglutide or placebo

8-12 weeks

Open-label extension

Participants in Part C receive open-label multiple ascending doses of maridebart cafraglutide

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AMG 133

Participant Groups

Group I: Part C: maridebart cafraglutide Experimental Treatment 1 Intervention

Up to 2 open-label, multiple ascending dose cohorts (cohorts 12 to 13) treated with doses previously studied in Part A and Part B.

Group II: Part B: maridebart cafraglutide Experimental Treatment 1 Intervention

Up to 4 multiple ascending dose cohorts (cohorts 7 to 10).

Group III: Part A: maridebart cafraglutide Experimental Treatment 1 Intervention

Up to 7 single ascending dose cohorts (cohorts 1 to 6 and cohort 11).

Group IV: Part A: Placebo Placebo Group 1 Intervention

Up to 7 single ascending dose cohorts (cohorts 1 to 6 and cohort 11).

Group V: Part B: Placebo Placebo Group 1 Intervention

Up to 4 multiple ascending dose cohorts (cohorts 7 to 10).

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London