Clinical trial NCT04143802: A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)
Official title: A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-10-29
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Have T2DM for at least 3 months before screening and are without advanced known possible complications of diabetes mellitus
* Have a glycated hemoglobin (HbA1c) value at lead-in and screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight change)
* Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive
* Male participants agree to use an effective method of contraception for the duration of the study plus 90 days, which corresponds to 4 months after the last investigational product dose
* Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or those who are postmenopausal

Exclusion Criteria:

* Have type 1 diabetes mellitus or latent autoimmune diabetes in adults
* Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
* Have a known clinically significant gastric emptying abnormality
* Have had an episode of severe hypoglycemia
* Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of \>500 milligrams per deciliter (mg/dL) at screening and/or Day-2. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening
* Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 3X upper limit of normal (ULN) at screening and/or Day -2

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 106
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943
timeFrame: Baseline through study completion (12 weeks)
measure: PK: Maximum Concentration (Cmax) of LY3437943
timeFrame: Baseline through study completion (12 weeks)
measure: Change from Baseline in Mean Daily Plasma Glucose (PG)
timeFrame: Baseline through Day 80
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Lenexa
country: United States
facility: PRA International
state: Kansas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.