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A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

ConditionsObesity or OverweightType 2 Diabetes Mellitus
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), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)

Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.

Body mass index (BMI) ≥27.0 kg/m²

History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

Disqualifiers

History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening

Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening

At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening

Self-reported change in body weight >5 kg within 3 months prior to screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Combination product

    Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.

  • Enicepatide

    Combination product

    Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Treatment groups

1,600 Participants
are divided into 4 treatment groups
Group A: Arm 1: PlaceboPlacebo comparator 1 intervention
Group B: Arm 2: Enicepatide Dosing Regimen 1Experimental treatment 1 intervention
Group C: Arm 3: Enicepatide Dosing Regimen 2Experimental treatment 1 intervention
Group D: Arm 4: Enicepatide Dosing Regimen 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent (%) Change from Baseline in Body Weight at Week 72

Time frame
Baseline through Week 72

Secondary outcomes

1

Percentage of Participants Achieving ≥5% Body Weight Loss from Baseline at Week 72

Time frame
Baseline and Week 72
2

Percentage of Participants Achieving ≥10% Body Weight Loss from Baseline at Week 72

Time frame
Baseline and Week 72
3

Percentage of Participants Achieving ≥15% Body Weight Loss from Baseline at Week 72

Time frame
Baseline and Week 72
4

Change from Baseline in Body Weight (kg) at Week 72

Time frame
Baseline through Week 72

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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