Taking people in ChinaPhase 3
Testing a once-weekly drug for weight loss in adults with diabetes
Compares weekly enicepatide with placebo for weight in adults with diabetes.
Key facts
- Who runs it
- Hoffmann-La Roche
- Where
- Beijing, Cangzhou, Changchun, Hefei, Herbin, Huizhou, Jinan, Kaifeng, Langfang, Luoyang, Nanjing, Ningbo, Pingxiang, Shanghai, Siping, Suzhou, Wuxi, Xi'an, Xianyang, Xuzhou, Yueyang, and Zhenjiang, ChinaSee the 25 sitesAlso in 22 other countries, 208 sites
- Trial code
- Registry title
- A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,600 people, planned
- Started
- 23 Mar 2026
- Expected to end
- 7 Aug 2028
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- Enicepatide
- Record updated
- 9 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 with type 2 diabetes who are overweight or have obesity. It tests the weekly drug enicepatide against placebo for weight management.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Type 2 diabetes with HbA1c from 6.5% (48 mmol/mol) to 10% (86 mmol/mol) at screening, and a body mass index (BMI) of 27.0 kg/m² or higher.
- Earlier treatment
- Must be on stable oral diabetes treatment for at least 3 months, or diet and exercise alone. Must have tried to lose weight with diet or exercise at least once without success. Cannot have used any GLP-1 receptor agonist-based drug within 6 months before randomization. DPP-4 inhibitors are not allowed.
- Biomarker or test result
- HbA1c from 6.5% (48 mmol/mol) to 10% (86 mmol/mol) on a laboratory test at screening.
Main reasons for not taking part
- Type 1 diabetes, or ever had ketoacidosis
- Severe low blood sugar in the last 6 months, or not noticing low blood sugar
- Weight change of more than 5 kg (11 lb) in the last 3 months
- Obesity caused by another hormone disease or by a genetic condition
- Heart attack, stroke, unstable angina or hospital stay for heart failure in the last 3 months
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
- Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy
- Body mass index (BMI) ≥27.0 kg/m\^2
- History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
Who cannot take part
- History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
- Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
- Self-reported change in body weight >5 kg within 3 months prior to screening
- Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed
- Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
- Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
- Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
- Poorly controlled hypertension at screening
- At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
- Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
Where in China
Also in 22 other countries, 208 sites
- Beijing Pinggu HospitalBeijing, ChinaTaking people
- Peking University People's HospitalBeijing, ChinaTaking people
- Cangzhou People's HospitalCangzhou, ChinaTaking people
- The First Hospital of Jilin UniversityChangchun, ChinaTaking people
- The Second People's Hospital of HefeiHefei, ChinaTaking people
- The Fourth Affiliated Hospital of Harbin Medical UniversityHerbin, ChinaTaking people
- Huizhou Central People's HospitalHuizhou, ChinaTaking people
- Jinan Central HospitalJinan, ChinaTaking people
- Huai He Hospital of Henan UniversityKaifeng, ChinaTaking people
- Hebei Petro China Central HospitalLangfang, ChinaTaking people
- The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaTaking people
- Affiliated Drum Tower Hospital of Nanjing University Medical SchoolNanjing, ChinaTaking people
- The Second Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
- The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaTaking people
- Pingxiang People's HospitalPingxiang, ChinaTaking people
- Shanghai Fifth People's Hospital Affiliated to Fudan UniversityShanghai, ChinaTaking people
- Shanghai Pudong New Area People's HospitalShanghai, ChinaTaking people
- Siping Central People's HospitalSiping, ChinaTaking people
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Wuxi People's HospitalWuxi, ChinaTaking people
- The First Affiliated Hospital of Xi'an Medical UniversityXi'an, ChinaTaking people
- Yan'an University Xianyang HospitalXianyang, ChinaTaking people
- The affiliated hospital of xuzhou medical universityXuzhou, ChinaTaking people
- Yueyang Central HospitalYueyang, ChinaTaking people
- Affiliated Hospital of Jiangsu UniversityZhenjiang, 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), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).
The 4 groups in the trial
- Arm 1: PlaceboPlacebo, for comparison
Treatment: Placebo
- Arm 2: Enicepatide Dosing Regimen 1Treatment being tested
Treatment: Enicepatide
- Arm 3: Enicepatide Dosing Regimen 2Treatment being tested
Treatment: Enicepatide
- Arm 4: Enicepatide Dosing Regimen 3Treatment being tested
Treatment: Enicepatide
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 and on the EU's official list of trials (CTIS).
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes
- Plain-language title
- Testing a once-weekly drug for weight loss in adults with diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 10 November 2026.
- Record updated
- 9 November 2026