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| ID | Type | Description | Link |
|---|---|---|---|
| J3H-MC-GZNI | Other Identifier | Eli Lilly and Company |
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Study terminated for strategic business reasons
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The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in adult participants with a healthy body max index (BMI) of 22 to 25 kilograms per square meter (kg/m2).
Participation in the study will last about 13 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3549492 Dose 1 | Experimental | Participants will receive LY3549492 orally |
|
| LY3549492 Dose 2 | Experimental | Participants will receive LY3549492 orally |
|
| Placebo | Placebo Comparator | Participants will receive placebo orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3549492 | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration | A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline through Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 24, Week 48 | |
| Number of Participants with Adverse Events Leading to Permanent Discontinuation of Study Intervention or Withdrawal | Baseline through Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
Have type 1 diabetes, latent autoimmune diabetes in adults, or a history of ketoacidosis or hyperosmolar coma
Have:
Have poorly controlled hypertension
Have any of the following cardiovascular conditions within 12 months prior to screening:
Have a history of New York Heart Association Functional Classification III or IV congestive heart failure
Have signs and symptoms of liver disease
Have a history of pancreatitis
Have taken medications or alternative remedies for weight loss or weight gain within 3 months 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Headlands Research - Scottsdale | Scottsdale | Arizona | 85260 | United States | ||
| Valley Clinical Trials, Inc. |
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 and 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 orally |
|
| Covina |
| California |
| 91723 |
| United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Great Lakes Clinical Trials - Andersonville | Chicago | Illinois | 60640 | United States |
| Alliance for Multispecialty Research, LLC | Lexington | Kentucky | 40509 | United States |
| Alliance for Multispecialty Research, LLC | Norman | Oklahoma | 73069 | United States |
| Trial Management Associates | Myrtle Beach | South Carolina | 29572 | United States |
| Viacar Recherche Clinique | Greenfield Park | J4V 2G8 | Canada |
| Apex Trials | Guelph | N1G 0B4 | Canada |
| OCT Research ULC | Kelowna | V1Y 1Z9 | Canada |
| Clinique Mémoire de Montréal | Montreal | H3G 1H9 | Canada |
| Ottawa Memory Clinic | Ottawa | K1Z 1G3 | Canada |
| Richmond Clinical Trials | Richmond | V6V 2L1 | Canada |
| Q&T Research Sherbrooke Inc. | Sherbrooke | J1J 2G2 | Canada |
| Toronto Memory Program | Toronto | M3B 2S7 | Canada |
| BioPharma Services | Toronto | M9L 3A2 | Canada |
| Diex Recherche Trois-Rivieres | Trois-Rivières | G9A 4P3 | Canada |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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