A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
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
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
Treatments tested in this trial
- Enicepatide
- Placebo
Treatment groups
300 Participants
are divided into 4 treatment groupsLocations
3The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)315010, NingboZhejiang, China
Peking University People's Hospital100044, Beijing China
Shanghai Fifth People's Hospital Affiliated to Fudan University201304, Shanghai China
Sponsors and collaborators
Hoffmann-La Roche
Lead sponsor
Source ClinicalTrials.gov