Active — Not RecruitingPhase 3

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease

Japan279 participantsStarted 2025-06-13

Plain-language summary

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight and proportion of participants with ≥ 5% reduction in body weight.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. hypertension: treated, or with SBP ≥ 140 mmHg, or DBP ≥ 90 mmHg at screening.
✓. dyslipidemia: treated, or with LDL \> 140 mg/dL (3.6 mmol/L), or triglycerides ≥ 150 mg/dL (1.7 mmol/L), or non-HDL cholesterol \> 170 mg/dL (4.4 mmol/L) or HDL \< 40 mg/dL (1.0 mmol/L) at screening.
✓. T2DM: diagnosed ≥ 180 days before screening, and treated with diet and exercise alone and/or a stable treatment for at least 90 days before screening with up to 3 oral glucose-lowering medications (as per local labeling) (except for glucagon-like peptide-1 receptor agonists \[GLP-1RA\] and dipeptidyl peptidase-4 \[DPP-4\] inhibitors), and have a HbA1c ≥ 7% and ≤ 10% (53-86 mmol/mol) at screening.
✓. Follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice, maintain a study log(s)/diary(ies), and complete required study visits and questionnaires.
✓. Perform self-monitoring blood glucose (SMBG) per protocol (only for participants with T2DM).

What they're measuring

Percent Change From Baseline in Body Weight at Week 72

Timeframe: Baseline and Week 72

Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72

Timeframe: Baseline and Week 72

Trial details

NCT IDNCT06987695

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-27

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