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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT07670416

Registry updated: 2026-10-08
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Description

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.

Interventions

  • 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.

Eligibility criteria

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

Conditions

Obesity Overweight Type 2 Diabetes Mellitus (T2DM)

Locations

  • The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
  • Yan'an University Xianyang Hospital — Xianyang, Shaanxi, China
  • The First Affiliated Hospital of Ningbo University(Ningbo First Hospital) — Ningbo, Zhejiang, China
  • Peking University People's Hospital — Beijing, China
  • The Second Hospital of Jilin University — Changchun, China
  • The Second Affiliated Hospital of Anhui Medical University — Hefei, China
  • The Fourth Affiliated Hospital of Harbin Medical University — Herbin, China
  • Huai'an First People's Hospital — Huai'an, China
  • Huzhou Central Hospital — Huzhou, China
  • Jinan Central Hospital — Jinan, China
  • Hebei Petro China Central Hospital — Langfang, China
  • Luoyang Third People's Hospital — Luoyang, China
  • The Affiliated Jiangning Hospital of Nanjing Medical University — Nanjing, China
  • Shanghai Tenth People's Hospital — Shanghai, China
  • Shanghai East Hospital — Shanghai, China
  • Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China
  • Shanghai Fifth People's Hospital Affiliated to Fudan University — Shanghai, China
  • The People's Hospital of Liaoning Province — Shenyang, China
  • Shenyang Fifth People Hospital — Shenyang, China
  • Hebei Medical University - The Second Hospital — Shijiazhuang, China
  • Zibo Municipal Hospital. — Zibo, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record