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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
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

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University People's Hospital
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BeijingChinaRecruiting
The Second Hospital of Jilin University
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ChangchunChinaRecruiting
The Second Affiliated Hospital Of Anhui Medical University
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HefeiChinaRecruiting
The Fourth Affiliated Hospital of Harbin Medical University
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HerbinChinaRecruiting
Huai'an First People's Hospital
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Huai'anChinaRecruiting
Huzhou Central Hospital
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HuzhouChinaRecruiting
Jinan Central Hospital
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JinanChinaRecruiting
Hebei Petro China Central Hospital
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LangfangChinaRecruiting
Luoyang Third People's Hospital
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LuoyangChinaRecruiting
The Affiliated Jiangning Hospital of Nanjing Medical University
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NanjingChinaRecruiting
The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
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NingboChinaRecruiting
Shanghai Fifth People's Hospital Affiliated to Fudan University
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ShanghaiChinaRecruiting
Shanghai East Hospital
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ShanghaiChinaRecruiting
Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting
Shanghai Tenth People's Hospital
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ShanghaiChinaRecruiting
Shenyang Fifth People Hospital
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ShenyangChinaRecruiting
The People's Hospital of Liaoning Province
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ShenyangChinaRecruiting
Hebei Medical University - The Second Hospital
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ShijiazhuangChinaRecruiting
Yan'an University Xianyang Hospital
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XianyangChinaRecruiting
The Second Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting
Zibo Municipal Hospital
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ZiboChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.