A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)

NCT04143802 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17137J1I-MC-GZBB
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943

  Baseline through study completion (12 weeks)

• PK: Maximum Concentration (Cmax) of LY3437943

  Baseline through study completion (12 weeks)

• Change from Baseline in Mean Daily Plasma Glucose (PG)

  Baseline through Day 80

Study Arms (3)

LY3437943

EXPERIMENTAL

LY3437943 administered subcutaneously (SC)

Drug: LY3437943

Dulaglutide

ACTIVE COMPARATOR

Dulaglutide administered SC

Drug: Dulaglutide

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

LY3437943 DRUG

Administered SC

LY3437943

Dulaglutide DRUG

Administered SC

Also known as: LY2189265

Dulaglutide

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

PRA International

Lenexa, Kansas, 66219, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 36354040 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

retatrutide; dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 29, 2019
• Study Start: December 18, 2019
• Primary Completion: December 28, 2020
• Study Completion: December 28, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01-15

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)