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

RecruitingPhase 3Ages 18 Years - anyAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Enicepatide
  • Placebo
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Where

21 sites
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Yan'an University Xianyang Hospital
Xianyang, China
The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
Ningbo, 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

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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