A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
- Conditions
- OverweightObesityType 2 Diabetes
- Interventions
- Drug: Placebo
- Registration Number
- NCT05872620
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
-
Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
-
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
-
Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:
- either diet/exercise alone or
- up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).
- Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
- Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
- Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
- Have had a history of chronic or acute pancreatitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 1 Orforglipron Participants will receive orforglipron administered orally. Orforglipron Dose 2 Orforglipron Participants will receive orforglipron administered orally. Orforglipron Dose 3 Orforglipron Participants will receive orforglipron administered orally. Placebo Placebo Participants will receive placebo
- Primary Outcome Measures
Name Time Method Mean Percent Change from Baseline in Body Weight Baseline, Week 72
- Secondary Outcome Measures
Name Time Method Mean Change from Baseline in Waist Circumference Baseline, Week 72 Mean Change from Baseline in Hemoglobin A1c (HbA1c) % Baseline, Week 72 Mean Change from Baseline in Fasting Glucose Baseline, Week 72 Mean Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 72 Mean Change from Baseline in Fasting Triglycerides Baseline, Week 72 Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol Baseline, Week 72 Mean Percent Change from Baseline in Fasting Insulin Baseline, Week 72 Mean Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 72 Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores Baseline, Week 72
Trial Locations
- Locations (135)
Advara HeartCare Joondalup
🇦🇺Joondalup, Western Australia, Australia
Cahaba Research - Pelham
🇺🇸Pelham, Alabama, United States
Novak Clinical Research - Tucson - North La Cholla Boulevard
🇺🇸Tucson, Arizona, United States
Yuma Clinical Trials
🇺🇸Yuma, Arizona, United States
AMCR Institute
🇺🇸Escondido, California, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Scroll for more (125 remaining)Advara HeartCare Joondalup🇦🇺Joondalup, Western Australia, Australia