A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05869903 |
Recruitment Status :
Active, not recruiting
First Posted : May 22, 2023
Last Update Posted : April 16, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Overweight Overweight or Obesity | Drug: Orforglipron Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 3000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | June 5, 2023 |
Estimated Primary Completion Date : | September 12, 2025 |
Estimated Study Completion Date : | September 24, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Orforglipron Dose 1
Participant will receive orforglipron administered orally.
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Drug: Orforglipron
Administered orally.
Other Name: LY3502970 |
Experimental: Orforglipron Dose 2
Participant will receive orforglipron administered orally.
|
Drug: Orforglipron
Administered orally.
Other Name: LY3502970 |
Experimental: Orforglipron Dose 3
Participant will receive orforglipron administered orally.
|
Drug: Orforglipron
Administered orally.
Other Name: LY3502970 |
Placebo Comparator: Placebo
Participants will be given placebo.
|
Drug: Placebo
Administered orally. |
- Mean Percent Change from Baseline in Body Weight [ Time Frame: Baseline to Week 72 ]
- Mean Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 72 ]
- Mean Change from Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, Week 72 ]
- Mean Percent Change from Baseline in Fasting non-HDL Cholesterol [ Time Frame: Baseline, Week 72 ]
- Mean Percent Change from Baseline in Fasting Triglycerides [ Time Frame: Baseline, Week 72 ]
- Mean Change from Baseline in Hemoglobin A1c (HbA1c) % [ Time Frame: Baseline, Week 72 ]
- Mean Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 72 ]
- Mean Percent Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 72 ]
- Mean Change from Baseline in Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, Week 72 ]
- Mean Change from Baseline in Short Form Version 2 (SF-36v2) Acute Form Domain Scores [ Time Frame: Baseline, Week 72 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05869903
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT05869903 |
Other Study ID Numbers: |
18559 J2A-MC-GZGP ( Other Identifier: Eli Lilly and Company ) 2022-502839-19-00 ( Other Identifier: Eli Lilly and Company ) U1111-1289-8877 ( Other Identifier: UTN Number ) |
First Posted: | May 22, 2023 Key Record Dates |
Last Update Posted: | April 16, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | ata are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting. |
Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
URL: | http://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Obesity Overweight Overnutrition Nutrition Disorders Body Weight |