A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Eli Lilly and Company70 sites in 4 countries546 target enrollmentNovember 10, 2023

ConditionsType 2 Diabetes

InterventionsOrforglipron Placebo

Overview

Phase: Phase 3
Intervention: Orforglipron
Conditions: Type 2 Diabetes
Sponsor: Eli Lilly and Company
Enrollment: 546
Locations: 70
Primary Endpoint: Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

Registry

clinicaltrials.gov

Start Date

November 10, 2023

End Date

September 15, 2025

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have Type 2 Diabetes (T2D)
•Have HbA1c ≥7.0% \[53 mmol/mol\] to ≤10.5% \[91 mmol/mol\]
•Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:
•insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
•insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
•metformin, or
•SGLT-2 inhibitor, or
•both metformin and SGLT-2 inhibitor.
•Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
•Have a Body Mass Index (BMI) ≥23.0 kg/m\^2 at baseline.

Exclusion Criteria

•Have New York Heart Association functional classification III-IV congestive heart failure.
•Have had any of the following cardiovascular conditions within 60 days prior to baseline.
•acute myocardial infarction
•cerebrovascular accident (stroke), or
•hospitalization for congestive heart failure.
•Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
•Have had chronic or acute pancreatitis any time.

Arms & Interventions

Orforglipron Dose 1

Participants will receive orforglipron orally.

Intervention: Orforglipron

Orforglipron Dose 2

Participants will receive orforglipron orally.

Intervention: Orforglipron

Orforglipron Dose 3

Participants will receive orforglipron orally.

Intervention: Orforglipron

Placebo

Participants will receive placebo orally.

Intervention: Placebo

Outcomes

Primary Outcomes

Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)

Time Frame: Baseline, Week 40

Secondary Outcomes

Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol(Baseline, Week 40)
Change from Baseline in Body Weight(Baseline, Week 40)
Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol))(Baseline to Week 40)
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)(Baseline to Week 40)
Percentage Change from Baseline in Body Weight(Baseline, Week 40)
Percentage of Participants Who Achieved Weight Loss of ≥10%(Baseline to Week 40)
Orforglipron Dose 3: Change from Baseline in HbA1c(Baseline, Week 40)
Change from Baseline in Fasting Serum Glucose(Baseline, Week 40)
Percentage of Participants Who Achieved Weight Loss of ≥15% from Baseline(Baseline to Week 40)
Percentage Change from Baseline in Triglycerides(Baseline, Week 40)
Change from Baseline in Systolic Blood Pressure(Baseline, Week 40)
Change from Baseline in Daily Insulin Glargine Dose(Baseline, Week 40)
Percentage of Participants Who Achieved Weight Loss of ≥5%(Baseline to Week 40)
Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary Scores(Baseline, Week 40)