A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

Conditions
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Obesity, Overweight, Type 2 Diabetes

Intervention / Treatment
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* Drug: Orforglipron
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

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: Double


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;|
| Placebo Comparator: Placebo<br>Participants will receive placebo | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change from Baseline in Body Weight |  | Baseline, Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |