A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Phase 3

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Orforglipron; Drug: Placebo

• Registration Number: NCT06109311
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-10-31
• Study Start: 2023-11-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 520

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orforglipron Dose 2	Orforglipron	Participants will receive orforglipron orally.
Orforglipron Dose 1	Orforglipron	Participants will receive orforglipron orally.
Orforglipron Dose 3	Orforglipron	Participants will receive orforglipron orally.
Placebo	Placebo	Participants will receive placebo orally.

Primary Outcome Measures

Name	Time	Method
Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 40

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (70)

MD First Research - Chandler; 🇺🇸 Chandler, Arizona, United States

Phoenix Clinical LLC; 🇺🇸 Phoenix, Arizona, United States

SanRo Clinical Research Group; 🇺🇸 Bryant, Arkansas, United States

Velocity Clinical Research, Gardena; 🇺🇸 Gardena, California, United States

Loma Linda University Health System; 🇺🇸 Loma Linda, California, United States

Western University of Health Sciences; 🇺🇸 Pomona, California, United States

Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.; 🇺🇸 Toluca Lake, California, United States

CMR of Greater New Haven, LLC; 🇺🇸 Hamden, Connecticut, United States

Care Access - Brandon; 🇺🇸 Brandon, Florida, United States

Encore Medical Research; 🇺🇸 Hollywood, Florida, United States

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