Obesity, Overweight, Type 2 Diabetes
Conditions
Brief summary
The main purpose of this study is to see how orforglipron, compared with placebo, helps improve glycemic control in participants with obesity or with overweight and type 2 diabetes. This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792). Participation in the study will last about 18 months.
Interventions
DRUGOrforglipron
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Phase 3b
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have body mass index (BMI) ≥25 kilograms per square meter (kg/m2) at screening * Have type 2 diabetes * Have hemoglobin A1c (HbA1c) ≥7% and ≤10% at screening * Have a history of at least one unsuccessful dietary effort to lose body weight
Exclusion criteria
* Have type 1 diabetes * Have an unstable body weight within 90 days prior to screening * Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening * Have acute or chronic hepatitis or pancreatitis * Are taking other medications or alternative remedies to manage weight loss
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 40 |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Baseline up to 72 weeks |
| Change from Baseline in HbA1c at Week 72 | Baseline, Week 72 |
| Change from Baseline in Fasting Glucose | Baseline up to 72 weeks |
| Percentage of Participants Achieving HbA1c of <7.0% | Baseline up to 72 weeks |
| Percentage of Participants Achieving Weight Reduction of ≥5% | Baseline up to 72 weeks |
| Change from Baseline in Waist Circumference | Baseline up to 72 weeks |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 72 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline up to 72 weeks |
| Percent Change from Baseline in Triglycerides | Baseline up to 72 weeks |
| Change from Baseline in EQ-5D-5L | Baseline, Week 72 |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron | Predose through Week 48 |
Countries
Argentina, China, Czechia, Germany, Japan, Puerto Rico, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed