What is enicepatide studying for obesity and Type 2 diabetes?

Enicepatide is being studied to understand its effects on weight management in people with obesity or overweight who have Type 2 diabetes. The study aims to evaluate its safety and how well it works compared to a placebo. Hoffmann-La Roche is sponsoring this research to find new treatment options for this condition.

Who may be eligible for this obesity and Type 2 diabetes clinical trial?

Adults aged 18 or older with Type 2 diabetes and a body mass index of 27.0 or higher may be eligible. Participants should have a history of unsuccessful weight loss efforts and not be currently using certain diabetes medications like GLP-1 receptor agonists or DPP-4 inhibitors. Please review eligibility criteria for more details.

Is there any cost to participate in this obesity and Type 2 diabetes clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs outside of the study procedures.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07351058

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Once-Weekly Enicepatide RO7795068 for Weight Management in Participants With Obesity or Overweight and Type 2 Diabetes

Led by Hoffmann-La Roche · Updated on 2026-05-26

1600

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating enicepatide, a drug that acts on two receptors related to blood sugar and weight control, for its effects on weight management in people with obesity or overweight who also have Type 2 diabetes mellitus T2DM. This Phase III study compares multiple doses of enicepatide to a placebo to assess both effectiveness and safety over a long period. 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 study uses a double-blind design, so neither participants nor researchers know who receives the active drug or placebo. Treatment lasts for 72 weeks, allowing detailed assessment of changes over time. Throughout the study, participants will regularly have their body weight measured to track percentage change from baseline, along with many other health indicators including blood sugar levels, cholesterol, blood pressure, and quality of life surveys. Safety will also be closely monitored through assessments of adverse events and specific health questionnaires. The total participation period extends through 72 weeks of treatment and follow-up to observe long-term effects.

CONDITIONS

Brief 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

You may qualify if you...

Able and willing to self-administer the study drug or receive injections from a trained individual if needed
Diagnosed with type 2 diabetes mellitus with HbA1c between 6.5% and 10% at screening
On stable oral diabetes therapy for at least 3 months before screening, excluding DPP-4 inhibitors and GLP-1 receptor agonists
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

You will not qualify if you...

History of type 1 diabetes mellitus or ketoacidosis or hyperosmolar state/coma within 12 months before screening
Experienced severe hypoglycemia or hypoglycemia unawareness in the past 6 months
Two or more fasting blood glucose readings above 270 mg/dL during screening
Body weight change greater than 5 kg within 3 months before screening
Obesity caused by other endocrine disorders or diagnosed genetic/syndromic obesity forms
Previous or planned surgical treatment for obesity (except liposuction or abdominoplasty over 1 year ago)
Known significant gastric emptying issues like severe gastroparesis
Poorly controlled high blood pressure at screening
Recent cardiovascular events within 3 months before screening such as heart attack or stroke
Use of any GLP-1 receptor agonist therapy within 6 months before randomization

Research Team

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

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

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