Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07351045

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

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

2000

Participants Needed

28

Research Sites

128 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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.

CONDITIONS

Official Title

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have a BMI of 30.0 kg/m2 or higher, or a BMI between 27.0 and less than 30.0 kg/m2 with at least one weight-related condition such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or weight-related cardiovascular disease
  • History of at least one unsuccessful attempt to lose weight through diet and exercise
  • Ability and willingness to self-administer the study drug or receive injections from a trained person if needed
Not Eligible

You will not qualify if you...

  • History of Type 1 or Type 2 diabetes, ketoacidosis, or hyperosmolar state/coma; prior gestational diabetes allowed if no ongoing diabetes
  • Weight change greater than 5 kg within 3 months before screening
  • Obesity caused by other endocrine disorders or genetic syndromes like Cushing's syndrome or Prader-Willi syndrome
  • Prior or planned surgery for obesity, except liposuction or abdominoplasty performed over 1 year before screening
  • Known severe gastric emptying problems
  • History of acute or chronic pancreatitis or significant gallbladder disease; prior gallbladder removal allowed if done at least 3 months before screening
  • Poorly controlled hypertension at screening
  • Recent (within 3 months) serious cardiovascular events including heart attack, stroke, unstable angina, or heart failure hospitalization
  • History of severe psychiatric disorders like unstable major depression, schizophrenia, bipolar disorder, or serious mood or anxiety disorders; stable depression or anxiety allowed if not on prohibited medications
  • Treatment with any GLP-1 receptor agonist 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: 28 locations

1

Pinnacle Research Group

Anniston, Alabama, United States, 36207

Actively Recruiting

2

Arizona Clinical Trials

Tucson, Arizona, United States, 85711

Actively Recruiting

3

Artemis Institute for Clinical Research, LLC

San Diego, California, United States, 92123

Actively Recruiting

4

Elevate Clinical Research

Gurnee, Illinois, United States, 60031

Actively Recruiting

5

Monroe Biomedical Research

Louisville, Kentucky, United States, 40213

Actively Recruiting

6

International Diabetes Center At Park Nicollet

Minneapolis, Minnesota, United States, 55416

Actively Recruiting

7

Clinvest Research LLC

Springfield, Missouri, United States, 65807

Actively Recruiting

8

Headlands Reseach- Summit

Portland, Oregon, United States, 97210

Actively Recruiting

9

Trial Management Associates

Myrtle Beach, South Carolina, United States, 29572

Actively Recruiting

10

Clinical Research Associates

Nashville, Tennessee, United States, 37203

Actively Recruiting

11

Elevate Clinical

Houston, Texas, United States, 77058

Actively Recruiting

12

Elevate Clinical

McAllen, Texas, United States, 78504

Actively Recruiting

13

CINME

Buenos Aires, Argentina, C1056ABI

Actively Recruiting

14

Paratus Clinical Western Sydney

Blacktown, New South Wales, Australia, 2148

Actively Recruiting

15

Aggarwal and Associates

Brampton, Ontario, Canada, L6T 0G1

Actively Recruiting

16

Wharton Medical Clinic

Hamilton, Ontario, Canada, L8L 5G8

Actively Recruiting

17

Kasugai Municipal Hospital

Aichi, Japan, 486-8510

Actively Recruiting

18

NTT Medical Center Sapporo

Hokkaido, Japan, 060-0061

Actively Recruiting

19

Hasegawa Medicine Clinic

Hokkaido, Japan, 066-0032

Actively Recruiting

20

Higashijujo Sakai Diabetes Internal Medicine Clinic

Tokyo, Japan, 114-0001

Actively Recruiting

21

Changhua Christian Hospital

Changhua, Taiwan, 50006

Actively Recruiting

22

Chia-Yi Christian Hospital

Chiayi City, Taiwan, 600

Actively Recruiting

23

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 80756

Actively Recruiting

24

Chung Shan Medical University Hospital

Taichung, Taiwan, 40201

Actively Recruiting

25

China Medical University Hospital

Taichung, Taiwan, 40447

Actively Recruiting

26

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

Actively Recruiting

27

National Taiwan University Hospital

Taipei, Taiwan, 10048

Actively Recruiting

28

Taipei Veterans General Hospital

Taipei, Taiwan, 112

Actively Recruiting

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Research Team

R

Reference Study ID Number: WC45725 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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