Tests enicepatide in adults with obesity or overweight, with or without diabetes
Tests enicepatide in adults with obesity or overweight, with or without diabetes.
Key facts
- Who runs it
- Hoffmann-La Roche
- Where
- Beijing, Changchun, Hefei, Herbin, Huai'an, Huzhou, Jinan, Langfang, Luoyang, Nanjing, Ningbo, Shanghai, Shenyang, Shijiazhuang, Xianyang, Zhengzhou, and Zibo, ChinaSee the 21 sites
- Trial code
- Registry title
- A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 300 people, planned
- Started
- 3 Jul 2026
- Expected to end
- 15 Mar 2028
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Enicepatide
- Placebo
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in China with obesity or overweight, with or without type 2 diabetes. It tests once-weekly enicepatide against placebo.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- With type 2 diabetes: BMI ≥24.0 kg/m^2. Without type 2 diabetes: BMI ≥28.0 kg/m^2, or BMI ≥24.0 and <28.0 kg/m^2 with at least one weight-related condition (prediabetes, high blood pressure, abnormal blood fats, fatty liver, sleep apnea or weight-related heart and blood vessel disease).
- Earlier treatment
- People cannot join if they had any approved or investigational GLP-1-RA-based therapy within 6 months before randomization, or other investigational therapy within 3 months before randomization or less than 5 elimination half-lives before randomization, whichever is longer.
Main reasons for not taking part
- History of type 1 diabetes
- Obesity caused by other hormone disorders
- Significant active or unstable major depression or other severe psychiatric disorder, or any lifetime suicide attempt
- History of acute or chronic pancreatitis or significant gallbladder disease
- Known allergy to the study drug or any reason GLP-1 RAs or GLP-1/GIP RAs cannot be used
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any planned major medical procedure or surgery during the study
- 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
- History of Type 1 diabetes mellitus (T1DM)
- Obesity induced by other endocrinologic disorders
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
- Any lifetime history of suicide attempt
- History of acute or chronic pancreatitis or clinically significant gallbladder disease
- 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
- History of any hematologic conditions that may interfere with HbA1c measurement
Where in China
- Peking University People's HospitalBeijing, ChinaTaking people
- The Second Hospital of Jilin UniversityChangchun, ChinaTaking people
- The Second Affiliated Hospital Of Anhui Medical UniversityHefei, ChinaTaking people
- The Fourth Affiliated Hospital of Harbin Medical UniversityHerbin, ChinaTaking people
- Huai'an First People's HospitalHuai'an, ChinaTaking people
- Huzhou Central HospitalHuzhou, ChinaTaking people
- Jinan Central HospitalJinan, ChinaTaking people
- Hebei Petro China Central HospitalLangfang, ChinaTaking people
- Luoyang Third People's HospitalLuoyang, ChinaTaking people
- The Affiliated Jiangning Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
- The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)Ningbo, ChinaTaking people
- Shanghai East HospitalShanghai, ChinaTaking people
- Shanghai Fifth People's Hospital Affiliated to Fudan UniversityShanghai, ChinaTaking people
- Shanghai Tenth People's HospitalShanghai, ChinaTaking people
- Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, ChinaTaking people
- Shenyang Fifth People HospitalShenyang, ChinaTaking people
- The People's Hospital of Liaoning ProvinceShenyang, ChinaTaking people
- Hebei Medical University - The Second HospitalShijiazhuang, ChinaTaking people
- Yan'an University Xianyang HospitalXianyang, ChinaTaking people
- The Second Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
- Zibo Municipal HospitalZibo, ChinaTaking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Enicepatide Dose 1Treatment being tested
Participants will receive enicepatide Dose 1.
Treatment: Enicepatide
- Enicepatide Dose 2Treatment being tested
Participants will receive enicepatide Dose 2.
Treatment: Enicepatide
- Enicepatide Dose 3Treatment being tested
Participants will receive enicepatide Dose 3.
Treatment: Enicepatide
- PlaceboPlacebo, for comparison
Participants will receive matching placebo.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus
- Plain-language title
- Tests enicepatide in adults with obesity or overweight, with or without diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 November 2026