A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

Launched by HOFFMANN-LA ROCHE · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new pill called RO7795081 to see if it helps adults who are overweight or have obesity manage their weight over time. The study is focused on people who have a body mass index (BMI) of 30 or higher, or who have a BMI between 27 and 30 along with at least one health condition related to their weight, such as high blood pressure, high cholesterol, sleep apnea, or heart disease. Importantly, people with diabetes are not eligible to join this study. Participants should also have tried and struggled with losing weight through diet and exercise in the past, and their weight should have been stable for at least three months before joining.

If you join the study, you will be randomly assigned to take either the RO7795081 pill or a placebo (a pill with no active medicine) every day, and neither you nor the researchers will know which one you are taking until the study is over. The study is designed to find out how well the medication works, how safe it is, and how well participants tolerate it. It’s important to note that people with certain health issues like recent heart problems, uncontrolled high blood pressure, some psychiatric conditions, or those who have had weight-loss surgery recently won’t be able to participate. This study is currently recruiting adults aged 18 to 74 of all genders who meet these criteria.

Gender

ALL

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 hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, cardiovascular disease
• • History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
• • A stable body weight for the 3 months prior to screening (maximum 5% body weight gain and/or loss)
• Exclusion Criteria:
• • Have a history or diagnosis of any type of diabetes mellitus (Type 1 diabetes \[T1D\], T2D, or rare forms of diabetes)
• • Have 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)
• • Participation in unbalanced/extreme diets or in an organized weight reduction program within 3 months of the screening visit or planning to engage in such diets or programs during the study
• • Prior or planned surgical treatment for obesity
• • Have a known, clinically significant gastric emptying abnormality
• • Have poorly controlled hypertension, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
• • Have 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 acute or chronic pancreatitis
• • 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), or had a suicide attempt within the last 1 year of screening