A Phase 3, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Participants Living with Overweight or Obesity with Type 2 Diabetes (RISE-2)

Condition studied

Overweight or Obesity with Type 2 Diabetes.

Investigational medicinal product(s)

Eligibility

Primary endpoint

Percent change in body weight.

Endpoint detail

Change in Hemoglobin A1C (HbA1c)., Change in body weight., Occurrence of ≥5%, ≥10%, and ≥15% reduction in body weight., Change in waist circumference., Occurrence of HbA1c <7.0%, <6.5%, and <5.7%., Change in Fasting Plasma Glucose (FPG)., Change in fasting insulin., Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)., Change in Systolic Blood Pressure (SBP) and in Diastolic Blood Pressure (DBP)., Percent change in total cholesterol, Low-Density Lipoprotein Cholesterol (LDL-C), High-Density Lipoprotein Cholesterol (HDL-C), non-HDL-C, Very-Low-Density Lipoprotein Cholesterol (VLDL-C), triglycerides, and Apolipoprotein B (ApoB)., Percent change in high-sensitivity C-Reactive Protein (hs-CRP)., Percent change in urine Albumin-Creatinine Ratio (uACR)., Concentrations of olatorepatide in plasma., Occurrence and magnitude of Anti-Drug Antibody (ADA) to olatorepatide., Occurrence of Neutralizing Antibody (Nab) to olatorepatide., Occurrence of Treatment-Emergent Adverse Events (TEAEs).