Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07351058

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

Led by Hoffmann-La Roche · Updated on 2026-04-24

1600

Participants Needed

36

Research Sites

124 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability and willingness to self-administer the study drug or receive injection from a trained individual if needed
  • Diagnosis of type 2 diabetes mellitus with HbA1c between 6.5% and 10% and on stable oral therapy for at least 3 months prior to screening (if applicable)
  • Body mass index (BMI) of 27.0 kg/m² or higher
  • History of at least one unsuccessful attempt to lose weight with diet or exercise
Not Eligible

You will not qualify if you...

  • History of type 1 diabetes mellitus or ketoacidosis or hyperosmolar state/coma within 12 months before screening
  • One or more episodes of severe hypoglycemia or hypoglycemia unawareness within 6 months before screening
  • Two or more fasting blood glucose readings over 270 mg/dL during screening
  • Weight change greater than 5 kg within 3 months before screening
  • Obesity caused by other endocrine disorders or genetic/syndromic obesity
  • Prior or planned surgical treatment for obesity (except liposuction or abdominoplasty done over 1 year ago)
  • Known significant gastric emptying problems
  • Poorly controlled hypertension at screening
  • Cardiovascular events (heart attack, stroke, unstable angina, or heart failure hospitalization) within 3 months before screening
  • Treatment with approved or investigational GLP-1 receptor-based therapies within 6 months before randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 36 locations

1

Lakeview Clinical Research

Guntersville, Alabama, United States, 35976

Actively Recruiting

2

Arizona Clinical Trials

Tucson, Arizona, United States, 85711

Actively Recruiting

3

Orange County Research Center

Lake Forest, California, United States, 92630

Actively Recruiting

4

Ark Clinical Research

Long Beach, California, United States, 90815

Actively Recruiting

5

Catalina Research Institute, LLC

Montclair, California, United States, 91763

Actively Recruiting

6

Prospective Research Innovations Inc.

Rancho Cucamonga, California, United States, 91730

Actively Recruiting

7

Emerson Clinical Research Institute

Washington D.C., District of Columbia, United States, 20009

Actively Recruiting

8

Progressive Medical Research

Port Orange, Florida, United States, 32127

Actively Recruiting

9

Elevate Clinical Research

Lake Charles, Louisiana, United States, 70605

Actively Recruiting

10

Centennial Medical Group

Columbia, Maryland, United States, 21045-5840

Actively Recruiting

11

Centricity Research Morehead City Multispeciality

Morehead City, North Carolina, United States, 28557

Actively Recruiting

12

Remington Davis Inc

Columbus, Ohio, United States, 43215

Actively Recruiting

13

Essential Medical Research

Tulsa, Oklahoma, United States, 74137

Actively Recruiting

14

Coastal Carolina Research Center

North Charleston, South Carolina, United States, 29405

Actively Recruiting

15

Circle Clinical Research

Sioux Falls, South Dakota, United States, 57104

Actively Recruiting

16

Velocity Clinical Research

Dallas, Texas, United States, 75230

Actively Recruiting

17

Juno Research, LLC

Houston, Texas, United States, 77040

Actively Recruiting

18

Manassas Clinical Research Center

Manassas, Virginia, United States, 20110

Actively Recruiting

19

Era Health Research

Redmond, Washington, United States, 98052

Actively Recruiting

20

CINME

Buenos Aires, Argentina, C1056ABI

Actively Recruiting

21

Paratus Clinical Western Sydney

Blacktown, New South Wales, Australia, 2148

Actively Recruiting

22

TGElliott Inc. dba BC Diabetes

Vancouver, British Columbia, Canada, V5Y 3W2

Actively Recruiting

23

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada, L6S 0C6

Actively Recruiting

24

LMC Clinical Research Inc

Toronto, Ontario, Canada, M4G 3E8

Actively Recruiting

25

Kasugai Municipal Hospital

Aichi, Japan, 486-8510

Actively Recruiting

26

Hasegawa Medicine Clinic

Hokkaido, Japan, 066-0032

Actively Recruiting

27

Higashijujo Sakai Diabetes Internal Medicine Clinic

Tokyo, Japan, 114-0001

Actively Recruiting

28

Changhua Christian Hospital

Changhua, Taiwan, 50006

Actively Recruiting

29

Chia-Yi Christian Hospital

Chiayi City, Taiwan, 600

Actively Recruiting

30

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756

Actively Recruiting

31

Chung Shan Medical University Hospital

Taichung, Taiwan, 40201

Actively Recruiting

32

China Medical University Hospital

Taichung, Taiwan, 40447

Actively Recruiting

33

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

Actively Recruiting

34

National Taiwan University Hospital

Taipei, Taiwan, 10048

Actively Recruiting

35

Taipei Veterans General Hospital

Taipei, Taiwan, 112

Actively Recruiting

36

Division of Endocrinology and Metabolism;Internal Medicine

Chiang Mai, Thailand, 50200

Actively Recruiting

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Research Team

R

Reference Study ID Number: WC45726 https://forpatients.roche.com/

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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