Health Trials

Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

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

About this trial

The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

hypertension,

dyslipidemia,

obstructive sleep apnea, or

cardiovascular (CV) disease.

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, or phentermine.

Unstable weight defined as self-reported change in body weight exceeding 5% within 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

  • Placebo

    Drug

    SC Injection

Treatment groups

2,340 Participants
are divided into 5 treatment groups
Group A: Ribupatide: Dose 1Experimental treatment 1 intervention
Group B: Ribupatide: Dose 2Experimental treatment 1 intervention
Group C: Ribupatide: Dose 3Experimental treatment 1 intervention
Group D: Ribupatide: Dose 4Experimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76

Time frame
Baseline, Week 76

Secondary outcomes

1

Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76

Time frame
Baseline, Week 76
2

Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight

Time frame
Baseline, Week 76
3

Change From Baseline in Waist Circumference

Time frame
Baseline, Week 76
4

Change From Baseline in Absolute Body Weight

Time frame
Baseline, Week 76

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kailera

Lead sponsor

Source ClinicalTrials.gov
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