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

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.

ClinicalTrials.gov IDNCT07670416

PhasePHASE3

Enrollment300

SponsorHoffmann-La Roche

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Obesity, Overweight, Type 2 Diabetes Mellitus (T2DM)

About this study

Interventions

Combination Product: Enicepatide — Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Combination Product: Placebo — Participants will receive matching placebo via SC injection as per the schedule in the protocol.

Primary outcomes

Percent Change From Baseline in Body Weight at Week 52 (Baseline through Week 52)

Eligibility information

Inclusion Criteria: * Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m\^2) for participants with type 2 diabetes mellitus (T2DM) * BMI ≥28.0 kg/m\^2 or BMI ≥24.0 and \<28.0 kg/m\^2 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 Exclusion Criteria: * 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 * Any lifetime history of suicide attempt * History of any hematologic conditions that may interfere with HbA1c measurement * History of acute or chronic pancreatitis or clinically signiﬁcant gallbladder disease * Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization * Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer * Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs

Study locations

The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450014 China
Yan'an University Xianyang Hospital, Xianyang, Shaanxi 712000 China
The First Affiliated Hospital of Ningbo University(Ningbo First Hospital), Ningbo, Zhejiang 315010 China
Peking University People's Hospital, Beijing, 100044 China
The Second Hospital of Jilin University, Changchun, 130041 China
The Second Affiliated Hospital of Anhui Medical University, Hefei, 230601 China
The Fourth Affiliated Hospital of Harbin Medical University, Herbin, 150001 China
Huai'an First People's Hospital, Huai'an, China
Huzhou Central Hospital, Huzhou, 313000 China
Jinan Central Hospital, Jinan, 250013 China

Showing 10 of 21 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.