Current partner codePEPTIDESDE
NCT04143802·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

72

Locations

4

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

LY3437943

Administered SC

DRUG

Dulaglutide

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Oct 29, 2019

  2. Study start

    Dec 18, 2019

  3. Primary completion

    Dec 28, 2020

  4. Study completion

    Dec 28, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Jan 20, 2021

Outcomes

What the study measures.

Primary outcomes

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame · Baseline through Day 106

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

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

Time frame · Baseline through study completion (12 weeks)

PK: AUC of LY3437943

PK: Maximum Concentration (Cmax) of LY3437943

Time frame · Baseline through study completion (12 weeks)

PK: Cmax of LY3437943

Change from Baseline in Mean Daily Plasma Glucose (PG)

Time frame · Baseline through Day 80

Change from baseline in mean daily PG from 6-point PG profile

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

4 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Miami Research Associates

Miami, Florida, United States

PRA International

Lenexa, Kansas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Related trials

More studies on Retatrutide.

Related PeptideStat pages

Put the record in context.

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