Enicepatide in people who are overweight or obese, with or without Type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating enicepatide, a dual GLP-1/GIP receptor agonist, versus placebo as a weight-management therapy. Participants include adults with obesity or overweight, with at least one weight-related condition, and those with Type 2 diabetes and obesity/overweight. All participants will follow a reduced-calorie diet and increased physical activity; enicepatide or placebo is added on to this lifestyle plan. Primary goals center on weight change and safety over the study period in non-diabetic and diabetic cohorts. The trial is sponsored by Hoffmann-La Roche and conducted at several sites in China.

Why it matters

Who can join: the full rules

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

Where it's running

• The Second Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Yan'an University Xianyang Hospital
  Xianyang, Shaanxi, China Recruiting
• The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
  Ningbo, Zhejiang, China Recruiting
• Peking University People's Hospital
  Beijing, China Recruiting
• The Second Hospital of Jilin University
  Changchun, China Recruiting
• The Second Affiliated Hospital of Anhui Medical University
  Hefei, China Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.