A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease

Metabolic Disorder
Obesity
Cardiovascular Disorder
Cardiovascular Disease

For Medical Professional
Download

Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Trial Identifier NCT07918846, WC46385, 2026-526958-14-00

Condition Overweight, Obesity, Cardiovascular Disease

Official Title A Phase III, Randomized, Double-Blind, Placebo-controlled, Trial to Evaluate the Efficacy and Safety of Enicepatide in Participants With Overweight or Obesity and Cardiovascular Disease

Study Summary

The purpose of this study is to evaluate the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), as a therapy to reduce the risk of major adverse cardiovascular events (MACE) in adults living with overweight or obesity and established cardiovascular disease (CVD), with or without type 2 diabetes mellitus (T2DM).

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

Inclusion Criteria

Body Mass Index (BMI) ≥25.0 kilograms per meter square (kg/m2)
Have established and stable cardiovascular disease (CVD)
Participants should be treated with stable (per investigator judgment) background therapy for CVD, such as hyperlipidemia and T2DM (if relevant), as per local and international guidelines, excluding use of GLP-1 RA-based therapies
For participants with T2DM: HbA1c ≤10% based on central laboratory assessment at Screening

Exclusion Criteria

History of type 1 diabetes mellitus, or any lifetime history of ketoacidosis or hyperosmolar state/coma within 12 months prior to Screening
Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study per investigator judgment
Any preplanned major medical procedure or surgery at the time of Screening including planning to have a surgical, endoscopic, or device treatment for obesity
Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
Chronic dialysis (e.g., chronic hemodialysis, chronic peritoneal dialysis)

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

For the latest version of this information please go to www.forpatients.roche.com

Link to Third Party Site

The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

Request a call back

First Name

Last Name

lblFpPhoneNumber

Products

When can we call you? (Free Service) 5am to 9am PST 9am to 1pm PST 1pm to 5pm PST

Don't want to wait for a callback ? Call us now

For Visitors from United States, our Privacy Statement can be reviewed below:
https://www.gene.com/privacy-policy

For Visitors from Canada, our Privacy Statement can be reviewed below:

http://www.rochecanada.com/en/content/footer-items/privacy.html

A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

YOU ARE ABOUT TO LEAVE THE GENENTECH CLINICAL TRIALS WEBSITE

Link to Third Party Site

Contact Genentech

Contact the hospital directly

Thank you

Request a call back

Find participating medical centers and current study status in each of them

A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease

For the latest version of this information please go to www.forpatients.roche.com