RecruitingPhase 3

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well different doses of enicepatide (RO7795068) help with weight management and how safe they are. It compares the drug with a placebo, which has no active drug. It is for people without type 2 diabetes who have obesity, or who are overweight with at least one weight-related health problem.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a body mass index (BMI), a measure of weight compared with height, of 30 or higher.
  • Or have a BMI of 27 to less than 30 and at least one weight-related health problem, such as prediabetes, high blood pressure, unhealthy blood fat levels, breathing pauses during sleep, or heart or blood vessel disease.
  • Have tried at least once to lose weight through diet or exercise without success.
  • Be able and willing to inject the study drug yourself. If vision or physical limits prevent this, a trained person may give the injection.

Who can't join

  • Have ever had type 1 or type 2 diabetes, or a serious diabetes emergency involving acid buildup or very high blood sugar. Past diabetes during pregnancy is allowed if there has been no diabetes since.
  • Have gained or lost more than 5 kilograms (about 11 pounds) in the 3 months before screening.
  • Have obesity caused by another hormone disorder or a diagnosed genetic condition.
  • Have had or plan to have weight-loss surgery. Liposuction or a tummy tuck is allowed if done more than 1 year before screening.
  • Have a serious problem with food leaving the stomach, past or current swelling of the pancreas, or serious gallbladder disease. Gallstone-related pancreas swelling or gallbladder disease may be allowed if gallbladder removal fixed the problem at least 3 months before screening.
  • Have poorly controlled high blood pressure, or had a heart attack, stroke, mini-stroke, unstable heart-related chest pain, or hospital stay for heart failure in the 3 months before screening.
  • Have a history of serious active or unstable major depression or another severe mental health disorder. Stable major depression or ongoing general anxiety may be allowed if the study doctor expects it to stay stable and you take no medicines banned by the study.
  • Have used an approved or experimental GLP-1-based medicine, a type of medicine studied for blood sugar or weight control, within 6 months before assignment to a study group.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (44)

AL

AZ

CA

CT

GA

HI

IL

KY

LA

MA

MD

MN

MO

MS

NY

OH

OK

OR

PA

SC

SD

TN

TX

UT

WI