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A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

ConditionObesity or Overweight
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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body mass index (BMI) greater than or equal to (≥)30.0 kg/m²; or

BMI ≥27.0 kg/m² and <30.0 kg/m² with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease

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

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

Disqualifiers

History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.

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

Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)

Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.

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

2,000 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

Percentage of Participants Achieving ≥20% Body Weight Loss from Baseline at Week 72

Time frame
Baseline and 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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