NCT07670416RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 3 Jul 2026
- Primary completion date
- 24 Feb 2028
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07670416
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 3 Jul 2026 to the primary completion date, 24 Feb 2028
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- History of any hematologic conditions that may interfere with HbA1c measurement
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Second Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| The Second Affiliated Hospital Of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| The Fourth Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Herbin | China | Recruiting |
| Huai'an First People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Recruiting |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Recruiting |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Hebei Petro China Central Hospital Coordinator of this site? Confirm its status | Langfang | China | Recruiting |
| Luoyang Third People's Hospital Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| The Affiliated Jiangning Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The First Affiliated Hospital of Ningbo University(Ningbo First Hospital) Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| Shanghai Fifth People's Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shenyang Fifth People Hospital Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| The People's Hospital of Liaoning Province Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Hebei Medical University - The Second Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Yan'an University Xianyang Hospital Coordinator of this site? Confirm its status | Xianyang | China | Recruiting |
| The Second Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Zibo Municipal Hospital Coordinator of this site? Confirm its status | Zibo | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.