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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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
The Second Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Huai'an First People's Hospital
RECRUITING
Huai'an
Huzhou Central Hospital
RECRUITING
Huzhou
Jinan Central Hospital
RECRUITING
Jinan
Hebei Petro China Central Hospital
RECRUITING
Langfang
Luoyang Third People's Hospital
RECRUITING
Luoyang
The Affiliated Jiangning Hospital of Nanjing Medical University
RECRUITING
Nanjing
The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
RECRUITING
Ningbo
Shanghai East Hospital
RECRUITING
Shanghai
Shanghai Fifth People's Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Shanghai Tenth People's Hospital
RECRUITING
Shanghai
Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shenyang Fifth People Hospital
RECRUITING
Shenyang
Hebei Medical University - The Second Hospital
RECRUITING
Shijiazhuang
Yan'an University Xianyang Hospital
RECRUITING
Xianyang
The Second Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Zibo Municipal Hospital.
RECRUITING
Zibo
Contact Information
Primary
Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Backup
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Time Frame
Start Date: 2026-07-03
Estimated Completion Date: 2028-03-15
Participants
Target number of participants: 300
Treatments
Experimental: Enicepatide Dose 1
Participants will receive enicepatide Dose 1.
Experimental: Enicepatide Dose 2
Participants will receive enicepatide Dose 2.
Experimental: Enicepatide Dose 3
Participants will receive enicepatide Dose 3.
Placebo_comparator: Placebo
Participants will receive matching placebo.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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