Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZBB | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to learn about the side effects of LY3437943 when given to participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943, dulaglutide, or placebo given just under the skin. For each participant, the study will last up to about 5 months and will include 16 visits to the study center.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3437943 | Experimental | LY3437943 administered subcutaneously (SC) |
|
| Dulaglutide | Active Comparator | Dulaglutide administered SC |
|
| Placebo | Placebo Comparator | Placebo administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3437943 | Drug | Administered SC |
| |
| Dulaglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 106 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943 | PK: AUC of LY3437943 | Baseline through study completion (12 weeks) |
| PK: Maximum Concentration (Cmax) of LY3437943 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Miami Research Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36354040 | Derived | Urva S, Coskun T, Loh MT, Du Y, Thomas MK, Gurbuz S, Haupt A, Benson CT, Hernandez-Illas M, D'Alessio DA, Milicevic Z. LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. Lancet. 2022 Nov 26;400(10366):1869-1881. doi: 10.1016/S0140-6736(22)02033-5. Epub 2022 Oct 27. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729679 | retatrutide |
| C555680 | dulaglutide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Administered SC |
|
|
| Placebo | Drug | Administered SC |
|
PK: Cmax of LY3437943
| Baseline through study completion (12 weeks) |
| Change from Baseline in Mean Daily Plasma Glucose (PG) | Change from baseline in mean daily PG from 6-point PG profile | Baseline through Day 80 |
| Miami |
| Florida |
| 33143 |
| United States |
| PRA International | Lenexa | Kansas | 66219 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| D004700 | Endocrine System Diseases |