A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication. This study includes 3 periods as follows: screening and lead-in period: up to 4 weeks treatment period: 52 weeks, including 20 weeks of dose escalation, and safety follow-up period: 2 weeks.

Official Title
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A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Orforglipron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have Type 2 Diabetes (T2D) Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening. Are of stable weight (±5%) for at least 90 days prior to screening 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 BMI ≥23.0 kilogram/square meter (kg/m²) at screening. Exclusion Criteria: Have Type 1 Diabetes (T1D). Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization. Have New York Heart Association functional classification IV congestive heart failure. Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization. acute myocardial infarction cerebrovascular accident (stroke), or hospitalization for congestive heart failure Have acute or chronic hepatitis and pancreatitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orforglipron Dose 1<br>Participants will receive orforglipron administered orally. | Drug: Orforglipron<br>* Administered orally<br>* Other names: LY3502970;|
| Experimental: Orforglipron Dose 2<br>Participants will receive orforglipron administered orally. | Drug: Orforglipron<br>* Administered orally<br>* Other names: LY3502970;|
| Experimental: Orforglipron Dose 3<br>Participants will receive orforglipron administered orally. | Drug: Orforglipron<br>* Administered orally<br>* Other names: LY3502970;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) |  | Baseline through Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Hemoglobin A1c (HbA1c) |  | Baseline, Week 52 | 
| Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol) |  | Week 52 | 
| Percentage of Participants who Achieve HbA1c ≤6.5% (<48 mmol/mol) |  | Week 52 | 
| Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol) |  | Week 52 | 
| Change from Baseline in Fasting Serum Glucose |  | Baseline, Week 52 | 
| Change from Baseline in Body Weight |  | Baseline, Week 52 | 
| Percentage of Participants who Achieve Weight Loss of ≥5% |  | Week 52 | 
| Percentage of Participants who Achieve Weight Loss of ≥10% |  | Week 52 | 
| Percentage of Participants who Achieve Weight Loss of ≥15% |  | Week 52 | 
| Change from Baseline in Waist Circumference |  | Baseline, Week 52 | 
| Change from Baseline in Body Mass Index (BMI) |  | Baseline, Week 52 | 
| Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) |  | Baseline, Week 52 |