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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZQJ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the efficacy and safety of retatrutide compared with placebo for body weight reduction.
Participation in the study will last about 65 weeks and may include about 18 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retatrutide Dose 1 | Experimental | Participants will receive retatrutide subcutaneously (SC) |
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| Retatrutide Dose 2 | Experimental | Participants will receive retatrutide 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Systolic Blood Pressure | Baseline, Week 56 | |
| Change from Baseline in Waist Circumference | Baseline, Week 56 | |
| Percent Change from Baseline in Non-High-Density Lipoprotein (HDL) Cholesterol |
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Inclusion Criteria:
Have a body mass index (BMI) of:
Have at least one unsuccessful attempt to lose weight by dieting
Exclusion Criteria:
Have a self-reported change in body weight >5 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 |
|---|---|---|---|---|---|---|
| Artemis Institute for Clinical Research | Riverside | California | 92503 | United States | ||
| JEM Research Institute |
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| Label | URL |
|---|---|
| A Study of Retatrutide (LY3437943) in Participants with Obesity or Overweight (TRIUMPH-8) | 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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| Placebo | Drug | Administered SC |
|
| Baseline, Week 56 |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) | Baseline through Week 56 |
| Atlantis |
| Florida |
| 33462 |
| United States |
| Headlands Research Orlando | Orlando | Florida | 32806 | United States |
| Care Access - Tamarac | Tamarac | Florida | 33321 | United States |
| Care Access - Arlington Heights | Arlington Heights | Illinois | 60005 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| IMA Clinical Research Monroe - Armand | Monroe | Louisiana | 71201 | United States |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Clinvest Headlands Llc | Springfield | Missouri | 65807 | United States |
| IMA Clinical Research Warren | Warren Township | New Jersey | 07059 | United States |
| IMA Clinical Research Manhattan | New York | New York | 10036 | United States |
| Trial Management Associates - Wilmington - Floral Parkway | Wilmington | North Carolina | 28403 | United States |
| Cedar Health Research | Dallas | Texas | 75251 | United States |
| Headlands Research-El Paso | El Paso | Texas | 79902 | United States |
| Cedar Health Research - Euless | Euless | Texas | 76040 | United States |
| Cedar Health Research - Fort Worth | Fort Worth | Texas | 76132 | United States |
| Care Access - Houston | Houston | Texas | 77054 | United States |
| IMA Clinical Research San Antonio | San Antonio | Texas | 78229 | United States |
| FutureMeds - Birmingham | Birmingham | B21 9RY | United Kingdom |
| Layton Medical Centre | Blackpool | FY3 7EN | United Kingdom |
| Bradford on Avon Health Centre | Bradford-on-Avon | BA15 1DQ | United Kingdom |
| FutureMeds - Liverpool | Bromborough | CH62 6EE | United Kingdom |
| Cheadle Community Hospital | Cheadle | ST10 1NS | United Kingdom |
| HMC Health Group - Meadows Centre for Health | Hounslow | TW4 7NR | United Kingdom |
| St Bartholomew's Medical Centre | Oxford | OX4 1XB | United Kingdom |
| Atlantic Medical | Penzance | TR18 3DX | United Kingdom |
| The Adam Practice | Poole | BH16 5PW | United Kingdom |
| Woodstock Bower Surgery | Rotherham | S61 1AH | United Kingdom |
| Rame Group Practice | Torpoint | PL11 2TB | United Kingdom |
| Albany House Medical Centre | Wellingborough | NN8 4RW | United Kingdom |
| 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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