A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

Study Overview
=================
Brief Summary
-----------------
This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.

Official Title
-----------------
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 With Weight-Related Comorbidities (ATTAIN-1)

Conditions
-----------------
Obesity, Overweight, Overweight or Obesity

Intervention / Treatment
-----------------
* Drug: Orforglipron
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a BMI ≥30.0 kilogram/square meter (kg/m²), ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening: Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure). Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria: Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening. Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome. Have had a history of chronic or acute pancreatitis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>Participant will receive orforglipron administered orally. | Drug: Orforglipron<br>* Administered orally.<br>* Other names: LY3502970;|
| Experimental: Orforglipron Dose 2<br>Participant will receive orforglipron administered orally. | Drug: Orforglipron<br>* Administered orally.<br>* Other names: LY3502970;|
| Experimental: Orforglipron Dose 3<br>Participant will receive orforglipron administered orally. | Drug: Orforglipron<br>* Administered orally.<br>* Other names: LY3502970;|
| Placebo Comparator: Placebo<br>Participants will be given placebo. | Drug: Placebo<br>* Administered orally.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change from Baseline in Body Weight |  | Baseline to 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 Systolic Blood Pressure (SBP) |  | Baseline, Week 72 | 
| Mean Percent Change from Baseline in Fasting non-HDL Cholesterol |  | Baseline, Week 72 | 
| Mean Percent Change from Baseline in Fasting Triglycerides |  | 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 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 Version 2 (SF-36v2) Acute Form Domain Scores |  | Baseline, Week 72 |