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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZQL | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retatrutide Dose Escalation 1 | Experimental | Participants will receive retatrutide subcutaneously (SC) |
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| Retatrutide Dose Escalation 2 | Experimental | Participants will receive retatrutide SC |
|
| Retatrutide Dose Escalation 3 | Experimental | Participants will receive retatrutide SC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retatrutide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Waist Circumference | Baseline, Week 104 | |
| Percent Change from Baseline in Triglycerides | Baseline, Week 104 | |
| Change from Baseline in Systolic Blood Pressure |
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Inclusion Criteria:
Have a Body Mass Index (BMI) at screening
Have at least one unsuccessful attempt to lose weight by dieting
Exclusion Criteria:
Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days before screening
Have a prior or planned surgical treatment for obesity
Have type 1 diabetes or type 2 diabetes
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Have had within the past 90 days before screening:
Have New York Heart Association Functional Classification Class IV congestive heart failure
Have a history of chronic or acute pancreatitis
Have taken weight loss drugs, including over-the counter medications within 90 days prior to screening
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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 |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| Care Access - Huntington Beach |
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| Label | URL |
|---|---|
| A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight (TRIUMPH-9) | View source |
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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 should be approved by an independent review panel and researchers should sign a data sharing agreement.
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Phase 3b
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| Baseline, Week 104 |
| Percent Change from Baseline in High Sensitivity C-Reactive Protein | Baseline, Week 104 |
| Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-Lite-CT) Total Score | Baseline, Week 104 |
| Overall Treatment Satisfaction with Medication for Obesity (TS-MO) Scores | Week 104 |
| Pharmacokinetics (PK): Steady state Average Trough PK Concentration | Baseline through Week 104 |
| Huntington Beach |
| California |
| 92648 |
| United States |
| Los Angeles Institute for Metabolic Research | Los Angeles | California | 90015 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Encore Medical Research - Weston | Weston | Florida | 33331 | United States |
| Pacific Diabetes & Endocrine Center | Honolulu | Hawaii | 96817 | United States |
| Monroe Biomedical Research - Louisville | Louisville | Kentucky | 40213 | United States |
| Brigham and Women's Hospital Diabetes Program | Boston | Massachusetts | 02115 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| NYC Research INC | Long Island City | New York | 11106 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Care Access - Raleigh | Raleigh | North Carolina | 27607 | United States |
| New Phase Research and Development | Knoxville | Tennessee | 37909 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| Cedar Health Research - Texas Native Health | Dallas | Texas | 75235 | United States |
| Cedar Health Research | Dallas | Texas | 75251 | United States |
| Cedar Health Research - Fort Worth | Fort Worth | Texas | 76132 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| Dominion Medical Associates, Inc. | Richmond | Virginia | 23219 | United States |
| CAMC Institute for Academic Medicine | Charleston | West Virginia | 25304 | United States |
| Cicemo Srl | Buenos Aires | 1424 | Argentina |
| CARDIAMET Investigaciones Médicas | Buenos Aires | C1014ACP | Argentina |
| Stat Research S.A. | Buenos Aires | C1023AAB | Argentina |
| Centro de Investigaciones Metabólicas (CINME) | Buenos Aires | C1056ABI | Argentina |
| Centro Médico Viamonte | Buenos Aires | C1120AAC | Argentina |
| Aggarwal and Associates Limited | Brampton | L6T 0G1 | Canada |
| Med Trust Research | Courtice | L1E 2J5 | Canada |
| Winterberry Research Inc. | Hamilton | L8J 0B6 | Canada |
| Diex Recherche Inc. Division Joliette | Joliette | J6E 6A9 | Canada |
| Milestone Research Inc. | London | N5W 6A2 | Canada |
| Diex Recherche Inc. Division Quebec | Québec | G1V 4T3 | Canada |
| Diex Recherche Inc. Division Sherbrooke | Sherbrooke | J1L 0H8 | Canada |
| Canadian Phase Onward | Toronto | M3J 0K2 | Canada |
| Dr. Anil K. Gupta Medicine Professional Corporation | Toronto | M9V 4B4 | Canada |
| C.I.C. Mauricie inc. | Trois-Rivières | G8T 7A1 | Canada |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| 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 |
|---|---|
| C000729679 | retatrutide |
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