A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-WEEKLY RO7795068 ADMINISTERED TO PARTICIPANTS WITH OBESITY OR OVERWEIGHT AND TYPE 2 DIABETES

Not provided0 sites1,600 target enrollmentStarted: TBD

Overview

No summary available.

•Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
•Diagnosis of type 2 diabetes mellitus (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 anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
•Body mass index (BMI) >=27.0 kg/m^2
•History of >=1 self-reported unsuccessful diet/exercise effort to lose body weight

•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
•Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
•At least 2 confirmed fasting blood glucose values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
•Self-reported change in body weight >5 kg within 3 months prior to screening
•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)
•Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
•Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
•Poorly controlled hypertension at screening
•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
•Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

Sponsor

Not provided