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

Roche

Status and phase: Enrolling; Phase 2

Conditions: Obesity or Overweight

Treatments: Drug: RO7795081; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07081958

BP45702

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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340 participants in 8 patient groups, including a placebo group

Arm 1: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 2: RO7795081 Dosing Regimen 1

Experimental group

Treatment:

Drug: RO7795081

Arm 3: RO7795081 Dosing Regimen 2

Experimental group

Treatment:

Drug: RO7795081

Arm 4: RO7795081 Dosing Regimen 3

Experimental group

Treatment:

Drug: RO7795081

Arm 5: RO7795081 Dosing Regimen 4

Experimental group

Treatment:

Drug: RO7795081

Arm 6: RO7795081 Dosing Regimen 5

Experimental group

Treatment:

Drug: RO7795081

Arm 7: RO7795081 Dosing Regimen 6

Experimental group

Treatment:

Drug: RO7795081

Arm 8: RO7795081 Dosing Regimen 7

Experimental group

Treatment:

Drug: RO7795081