Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

ConditionObesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKailera

About this trial

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI ≥35 kilograms per square meter (kg/m²).

History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.

Disqualifiers

Current diagnosis or history of diabetes mellitus.

Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, and phentermine.

Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening.

Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ribupatide

    Drug

    SC Injection

  • Semaglutide

    Drug

    SC Injection

  • Placebo

    Drug

    SC Injection

Treatment groups

1,200 Participants
are divided into 4 treatment groups
Group A: Ribupatide: Dose 1Experimental treatment 1 intervention
Group B: Ribupatide: Dose 2Experimental treatment 1 intervention
Group C: SemaglutideActive comparator 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change From Baseline in Body Weight at Week 76

Time frame
Baseline, Week 76

Secondary outcomes

1

Percentage of Participants with ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight

Time frame
Baseline, Week 76
2

Change From Baseline in Waist Circumference

Time frame
Baseline, Week 76
3

Change From Baseline in Absolute Body Weight

Time frame
Baseline, Week 76
4

Percentage of Participants with ≥5% Reduction in Body Weight

Time frame
Baseline, Week 76

Other outcomes

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