Enicepatide trial for weight loss in adults with obesity or overweight
Tests enicepatide against placebo in adults with obesity or overweight.
Plain-language title generated from the registry record
Registry title: A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
Key facts
- Where
- Balatonfüred, Budapest XII, Budapest XIII, Budapest XXI, Debrecen, Szeged, and Szekesfehervar, HungarySee the 7 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity, or with overweight and a weight-related health problem, who do not have type 2 diabetes.
- Age
- 18 years or older.
- Sex
- Men and women can join.
- Disease stage
- BMI 30.0 kg/m^2 or higher; or BMI 27.0 kg/m^2 or higher and below 30.0 kg/m^2 with at least one weight-related health problem, such as prediabetes, high blood pressure, abnormal blood fats, sleep apnea or weight-related heart disease.
- Earlier treatment
- At least one earlier diet or exercise attempt to lose weight that did not work. No GLP-1-based therapy in the 6 months before randomization.
Main reasons for not taking part
- History of type 1 or type 2 diabetes
- Body weight change of more than 5 kg (11 lb) in the 3 months before screening
- Obesity caused by another hormone disorder or a single-gene or syndrome form of obesity
- Past or planned surgery for obesity
- History of pancreatitis or significant gallbladder disease (with limited exceptions)
Read by machine on 11 November 2026.
Where in Hungary
- DRC Kft.Balatonfüred, HungaryNo longer taking part
- Semmelweis UniversityBudapest XII, HungaryNo longer taking part
- Med-Tima Kft.Budapest XIII, HungaryNo longer taking part
- Szatmari-Med Kft.Budapest XXI, HungaryNo longer taking part
- University of DebrecenDebrecen, HungaryNo longer taking part
- University of SzegedSzeged, HungaryNo longer taking part
- Fejer Varmegyei Szent Gyoergy Egyetemi Oktato KorhazSzekesfehervar, HungaryNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07351045EU 2025-523104-71-00
- Record updated
- 9 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants must have at screening:; Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or; 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: 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; Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed; 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; 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; 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); Poorly controlled hypertension at screening; Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction).