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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZQD | Other Identifier | Eli Lilly and Company | |
| 2024-517431-43-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retatrutide | Experimental | Participants will receive Retatrutide subcutaneously (SC) |
|
| Placebo | Placebo Comparator | Participants will receive Placebo SC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retatrutide | Drug | Administered SC |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Pain Intensity Per Numeric Rating Scale | Baseline, up to 72 weeks | |
| Percent Change from Baseline in Body Weight | Baseline, up to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale | Baseline, up to 72 weeks | |
| Number of Participants with Reduction in Body Weight | Baseline, up to 72 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| 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 |
|---|---|---|---|---|---|---|
| MD First Research - Chandler | Recruiting | Chandler | Arizona | 85286 | United States |
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| Label | URL |
|---|---|
| A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain (TRIUMPH-7) | 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 must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Administered SC |
|
| Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS) |
| Baseline, up to 72 weeks |
| Change in Pain Interference as Measured by PROMIS | Baseline, up to 72 weeks |
| Change in Sleep as Measured by PROMIS | Baseline, up to 72 weeks |
| Change in Patient Reported Health Outcomes as Measured by Medical Outcomes Study 36-item Short Form Health Survey version 2 (SF-36v2) | Baseline, up to 72 weeks |
| Change in Waist Circumference | Baseline, up to 72 weeks |
| Change in Biomarkers of Inflammation as Measured by Blood Test | Baseline, up to 72 weeks |
| Change in Blood Pressure | Baseline, up to 72 weeks |
| Change in Glycemic Control | Baseline, up to 72 weeks |
| Percent Change in Total Cholesterol | Baseline, up to 72 weeks |
| Percent Change in Urine Albumin-to-Creatinine Ratio (UACR) | Baseline, up to 72 weeks |
| Tucson Orthopaedic Institute - North Wyatt Drive | Recruiting | Tucson | Arizona | 85712 | United States |
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| Ark Clinical Research - Fountain Valley | Recruiting | Fountain Valley | California | 92708 | United States |
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| St Joseph Heritage Healthcare | Recruiting | Fullerton | California | 92835 | United States |
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| Clinical Research Institute | Recruiting | Los Angeles | California | 90048 | United States |
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| Artemis Institute for Clinical Research | Recruiting | San Diego | California | 92123 | United States |
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| Alpine Clinical Research Center | Recruiting | Boulder | Colorado | 80301 | United States |
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| K2 Medical Research - Daytona Beach | Recruiting | Daytona Beach | Florida | 32114 | United States |
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| Flourish Research - Miami, LLC | Recruiting | Miami | Florida | 33135 | United States |
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| IMA Clinical Research St. Petersburg | Recruiting | St. Petersburg | Florida | 33704 | United States |
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| Care Access - Tampa | Recruiting | Tampa | Florida | 33625 | United States |
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| Conquest Research | Recruiting | Winter Park | Florida | 32789 | United States |
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| MedVadis Research Corporation | Recruiting | Waltham | Massachusetts | 02451 | United States |
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| Great Lakes Research Group, Inc. | Recruiting | Bay City | Michigan | 48706 | United States |
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| Clinvest Headlands Llc | Recruiting | Springfield | Missouri | 65807 | United States |
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| Center for Clinical Research | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
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| Altoona Center For Clinical Research | Recruiting | Duncansville | Pennsylvania | 16635 | United States |
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| New Phase Research and Development | Recruiting | Knoxville | Tennessee | 37909 | United States |
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| FutureSearch Trials of Neurology | Recruiting | Austin | Texas | 78731 | United States |
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| Mercy Family Clinic | Recruiting | Dallas | Texas | 75208 | United States |
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| Houston Research Institute | Recruiting | Houston | Texas | 77079 | United States |
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| Sovah Clinical Research-River District | Recruiting | Danville | Virginia | 24541 | United States |
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| Investigaciones Medicas Imoba Srl | Recruiting | Buenos Aires | C1056ABH | Argentina |
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| CIPREC | Recruiting | Buenos Aires | C1061AAS | Argentina |
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| Centro Médico Viamonte | Recruiting | Buenos Aires | C1120AAC | Argentina |
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| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Recruiting | Buenos Aires | C1425AGC | Argentina |
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| Fundación Respirar | Recruiting | Buenos Aires | C1426ABP | Argentina |
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| Centro de Investigaciones Clínicas Baigorria | Recruiting | Granadero Baigorria | 2152 | Argentina |
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| Centro Rosarino de Investigaciones Clinicas (CRICs) | Recruiting | Rosario | 2000 | Argentina |
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| Instituto Médico Catamarca IMEC | Recruiting | Rosario | 2000 | Argentina |
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| Centro de Diagnóstico y Rehabilitación (CEDIR) | Recruiting | Santa Fe | 3000 | Argentina |
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| Aggarwal and Associates Limited | Recruiting | Brampton | L6T 0G1 | Canada |
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| Winterberry Research Inc. | Recruiting | Hamilton | L8J 0B6 | Canada |
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| Bluewater Clinical Research Group Inc. | Recruiting | Sarnia | N7T 4X3 | Canada |
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| Care Access - Cape Breton | Recruiting | Sydney | B1M 0A1 | Canada |
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| Dr. Anil K. Gupta Medicine Professional Corporation | Recruiting | Toronto | M9V 4B4 | Canada |
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| Podlaskie Centrum Psychogeriatrii | Completed | Bialystok | 15-756 | Poland |
| 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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