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Enicepatide for weight loss in adults with overweight or obesity without Type 2 diabetes

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes

Phase 3 Interventional Hoffmann-La Roche · NCT07351045

This study will test whether different doses of enicepatide help adults with overweight or obesity who do not have Type 2 diabetes lose weight compared with placebo and are safe.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2000 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Locations28 sites (Anniston, Alabama and 27 other locations)
Trial IDNCT07351045 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares multiple doses of enicepatide, a dual GLP-1/GIP receptor agonist, with placebo for weight management in adults without Type 2 diabetes. Eligible participants have a BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with at least one weight-related comorbidity and a history of unsuccessful diet/exercise attempts. Participants will receive enicepatide or placebo injections and will self-administer or receive injections from a trained individual, with regular clinic visits to measure weight and monitor safety. The study focuses on weight change and safety outcomes to determine whether enicepatide produces clinically meaningful weight loss.

Who should consider this trial

Good fit: Adults with BMI ≥30, or BMI ≥27 with at least one weight-related comorbidity, who do not have Type 2 diabetes, have tried and not succeeded with diet/exercise, and can self-administer or receive injections are ideal candidates.

Not a fit: People with Type 1 or Type 2 diabetes, recent large weight changes, obesity from endocrine disorders (e.g., Cushing's), or those unable or unwilling to receive injections are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, enicepatide could provide a new prescription option to help people with overweight or obesity lose significant weight and reduce related health risks.

How similar studies have performed: Other dual GLP-1/GIP agonists have produced substantial weight loss in Phase 2 and Phase 3 programs, so this mechanism has shown promising results in similar approaches.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must have at screening:

  1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
  2. BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)

Exclusion Criteria:

* History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
* Self-reported change in body weight \>5 kg within 3 months prior to screening
* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
* History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.
* Poorly controlled hypertension at screening
* Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.
* Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.
* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

Where this trial is running

Anniston, Alabama and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Obesity or Overweight
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.