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A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

ConditionsObesityOverweightType 2 Diabetes Mellitus (T2DM)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m²) for participants with type 2 diabetes mellitus (T2DM)

BMI ≥28.0 kg/m² or BMI ≥24.0 and <28.0 kg/m² and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM

Agreement to adhere to the contraception requirements

Disqualifiers

History of Type 1 diabetes mellitus (T1DM)

Obesity induced by other endocrinologic disorders

Any planned major medical procedure or surgery during the study

History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enicepatide

    Combination product

    Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.

  • Placebo

    Combination product

    Participants will receive matching placebo via SC injection as per the schedule in the protocol.

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: Enicepatide Dose 1Experimental treatment 1 intervention
Group B: Enicepatide Dose 2Experimental treatment 1 intervention
Group C: Enicepatide Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change From Baseline in Body Weight at Week 52

Time frame
Baseline through Week 52

Secondary outcomes

1

Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52

Time frame
At Week 52
2

Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52

Time frame
At Week 52
3

Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52

Time frame
At Week 52
4

Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3

Time frame
At Week 52

Other outcomes

Sponsors and contacts

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

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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