A clinical study to evaluate the effects of RO7795068 in participants with obesity or overweight and type 2 diabetes

Prior treatment

• History of Type 1 Diabetes Mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
• 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.

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)

Lab values

• At least 2 confirmed fasting BG values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening

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)
• BMI ≥27.0 kg/m²
• Diagnosis of T2DM according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral AHM (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
• History of ≥ 1 self-reported unsuccessful diet/exercise effort to lose body weight