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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZPN | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction in participants who previously completed treatment with injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy) in the SURMOUNT-5 trial (NCT05822830).
All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. SURMOUNT-5 randomized participants to either injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy); therefore, all ATTAIN-MAINTAIN participants had prior exposure to one of these injectable incretin-based therapies before transitioning directly to orforglipron 12 mg capsule or placebo. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron | Experimental | Participants will receive orforglipron orally |
|
| Placebo | Placebo Comparator | Participants will receive placebo orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5 | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment | Week 52 | |
| Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5 | Week 52 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Research | Birmingham | Alabama | 35242 | United States | ||
| Cahaba Research - Pelham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42120723 | Derived | Aronne LJ, Horn DB, le Roux CW, Chao AM, Ho W, Halpern B, Griffin R, Xie C, Valderas EG, Lee CJ, Ribeiro A, Hyman DM, Glass L, Xavier N. Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trial. Nat Med. 2026 May 13. doi: 10.1038/s41591-026-04386-7. Online ahead of print. |
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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.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Phase 3b
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| Drug |
Administered orally |
|
| Change from Baseline in Body Weight |
| Baseline, Week 52 |
| Change from Baseline in Waist Circumference | Baseline, Week 52 |
| Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5 | Week 24 |
| Pelham |
| Alabama |
| 35124 |
| United States |
| Southern California Dermatology, Inc. | Santa Ana | California | 92701 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | United States |
| Prime Health and Wellness/SKYCRNG | Fayette | Mississippi | 39069 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Palm Research Center Tenaya | Las Vegas | Nevada | 89128 | United States |
| Palm Research Center Sunset | Las Vegas | Nevada | 89148 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| PharmQuest Life Sciences, LLC | Greensboro | North Carolina | 27408 | United States |
| Lillestol Research | Fargo | North Dakota | 58104 | United States |
| Alliance for Multispecialty Research, LLC | Norman | Oklahoma | 73069 | United States |
| Tribe Clinical Research, LLC | Greenville | South Carolina | 29607 | United States |
| WR-Clinsearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| The University of Texas Health Science Center at Houston | Bellaire | Texas | 77401 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | United States |
| PlanIt Research, PLLC | Houston | Texas | 77079 | United States |
| Southern Endocrinology Associates | Mesquite | Texas | 75149 | United States |
| Puerto Rico Medical Research | Ponce | 00717 | Puerto Rico |
| Wellness clinical Research Vega Baja | Vega Baja | 00694 | Puerto Rico |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D001836 | Body Weight Changes |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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