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

NCT07081958

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Obesity or Overweight

Interventions: RO7795081, Placebo

Countries: United States

This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for chronic weight management in adult participants with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (36)

Anniston, Alabama, United States
Lake Forest, California, United States
Rancho Cucamonga, California, United States
Sherman Oaks, California, United States
Spring Valley, California, United States
Waterbury, Connecticut, United States
Washington D.C., District of Columbia, United States
Clermont, Florida, United States
Maitland, Florida, United States
Union City, Georgia, United States
Oak Lawn, Illinois, United States
Ames, Iowa, United States
Butte, Montana, United States
Cedarhurst, New York, United States
Cary, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Rocky Mount, North Carolina, United States
Salisbury, North Carolina, United States
Statesville, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Norman, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Bristol, Tennessee, United States
Knoxville, Tennessee, United States
Knoxville, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
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