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Clinical Trials in China / NCT07670416
Recruiting Phase 3

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

NCT07670416 · tracked via the Priya Life Science China tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2026-07-03
Last updated
2026-09-10

Condition(s) studied

ObesityOverweightType 2 Diabetes Mellitus (T2DM)

Investigational drug(s) / intervention(s)

EnicepatidePlacebo

Enicepatide: Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.

Placebo: Participants will receive matching placebo via SC injection as per the schedule in the protocol.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (21)

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

More Hoffmann-La Roche trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07670416 on ClinicalTrials.gov ↗ ← All trials in China