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Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

ConditionsObesity With DiabetesOverweight With Diabetes
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 placebo on:

* Percent change in body weight * Change in hemoglobin A1c (HbA1c)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of type 2 diabetes mellitus (T2DM).

Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.

BMI ≥27 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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.

History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.

History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ribupatide

    Drug

    SC Injection

  • Placebo

    Drug

    SC Injection

Treatment groups

1,156 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

Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

Time frame
Baseline, Week 76
2

Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76

Time frame
Baseline, Week 76

Secondary outcomes

1

Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

Time frame
Baseline, Week 76
2

Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76

Time frame
Baseline, Week 76
3

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

Time frame
Baseline, Week 76
4

Change From Baseline in Waist Circumference

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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