Actively Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Once-Weekly Enicepatide RO7795068 in Adults With Obesity or Overweight Without Type 2 Diabetes
Led by Hoffmann-La Roche · Updated on 2026-06-01
2000
Participants Needed
73
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of enicepatide, a dual GLP-1GIP receptor agonist, for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III trial aims to assess the safety and effectiveness of multiple doses of enicepatide compared with placebo, focusing on body weight changes and related health outcomes. The study is sponsored by Hoffmann-La Roche and targets participants with specific body mass index criteria and weight-related health conditions. Participants will be randomly assigned to one of four groups three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The treatment period lasts 72 weeks, during which the participants receive regular doses as per their assigned group. Throughout the study, participants will be monitored for changes in body weight, waist circumference, blood sugar levels, cholesterol, blood pressure, and quality of life measures. Assessments include physical exams, questionnaires, and imaging such as MRI to measure body composition. Safety is closely tracked through adverse event reporting and mental health assessments. The total participation duration extends through the 72-week treatment and evaluation period, with detailed follow-up on various health indicators.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Body mass index (BMI) of 30.0 kg/m2 or higher; or BMI between 27.0 and less than 30.0 kg/m2 with at least one weight-related health 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 or exercise
- Ability and willingness to self-administer the study drug or receive injections from a trained person if needed
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 diabetes since
- Weight change greater than 5 kg within 3 months before screening
- Obesity due to other hormonal disorders or genetic/syndromic obesity forms
- Prior or planned obesity surgery; liposuction or abdominoplasty allowed if done more than 1 year before screening
- Known severe gastric emptying problems
- History of acute or chronic pancreatitis or significant gallbladder disease unless treated by surgery over 3 months ago
- Poorly controlled high blood pressure at screening
- Recent major cardiovascular events or hospitalizations within 3 months
- History of unstable or severe psychiatric disorders, except stable mild depression or anxiety without prohibited medications
- Use of any GLP-1 receptor agonist therapies within 6 months before randomization
Research Team
R
Reference Study ID Number: WC45725 https://forpatients.roche.com/ No attachments to email below.
F
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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