A clinical study to evaluate the effects of RO7795068 in participants with obesity or overweight without type 2 diabetes.

Prior treatment

• 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
• Prior or planned surgical treatment for obesity Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
• 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.

Other illness

• 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)

Other

• Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)

• Age ≥ 18 years at the time of signing Informed Consent Form
• Ability and willingness to comply with all aspects of the protocol including completion of all procedures, study visits, questionnaires, assessments for the duration of the study
• Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
• Body mass index (BMI) ≥ 30.0 kg/m2 OR BMI ≥ 27.0 and <30.0 kg/m2 and diagnosed with at least one of the following weight-related comorbidities: – Prediabetes as defined by the 2025 American Diabetes Association (ADA) Standards of Medical Care in Diabetes, i.e., HbA1c 5.7–6.4% (39–47 mmol/mol) or fasting plasma glucose 100–125 mg/dL (5.6–6.9 mmol/L) as determined by laboratory test during screening – Hypertension: defined as current stable use (minimum 4 weeks prior to screening) of blood pressure lowering agents initiated for hypertension, or with systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥ 80 mm Hg during screening – Dyslipidemia: defined as current stable use (minimum 4 weeks prior to screening) of lipid-lowering agents initiated for dyslipidemia, or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) < 40 mg/dL (1.0 mmol/L) for men or HDL < 50 mg/dL (1.3 mmol/L) for women as determined by laboratory test during screening – Obstructive sleep apnea – Weight-related cardiovascular disease (including, but not limited to, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure)
• History of ≥ 1 self-reported unsuccessful diet/exercise effort to lose body weight
• Agreement to adhere to the contraception requirements