Enicepatide for Weight Management in Obesity or Overweight

This study is testing a medication called enicepatide to see how well it helps with weight management and if it's safe. Enicepatide is a dual GLP-1/GIP receptor agonist, which means it works on two natural body systems that help control appetite and how your body uses sugar. You could join if you are 18 or older and have obesity (a Body Mass Index, or BMI, of 30 or higher) or are overweight (BMI 27-30) with at least one weight-related health issue like high blood pressure or prediabetes. The study will compare enicepatide to a placebo (an inactive substance) over 72 weeks to see how much your body weight changes. The study is currently recruiting participants.

Study design
This is an interventional study planning to enroll 2000 participants. It compares enicepatide to a placebo, with both given once weekly.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your body weight will be measured from the beginning of the study through Week 72.

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NCT07351045

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

Recruiting
PHASE3Ages 18+InterventionalTreatment
Hoffmann-La Roche
~2,000 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:PlaceboEnicepatide

At a glance

Recruiting sites
195 of 195 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent (%) Change from Baseline in Body Weight at Week 72
Measured over Baseline through Week 72
Obesity or Overweight
195 sites across 74 states
Texas11
China11
Germany11
Poland10
France9
South Korea8
Taiwan8
Argentina7
  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche
Reference Study ID Number: WC45725 https://forpatients.roche.com/ No attachments to email below.
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must have at screening:
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
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
  • Percent (%) Change from Baseline in Body Weight at Week 72Baseline through Week 72