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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT04143802 (opens ClinicalTrials.gov in a new tab)Other id17137Other idJ1I-MC-GZBB
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
72 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
18 Dec 2019
Primary completion
28 Dec 2020
Completion
28 Dec 2020
First posted
29 Oct 2019
Last update posted
20 Jan 2021
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 1

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

    NCT04143802

    18 Dec 2019 to 28 Dec 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • LY3437943Drug
  • DulaglutideDrug
  • PlaceboDrug

Arms3

  • Experimental

    LY3437943

    LY3437943 administered subcutaneously (SC)

  • Active comparator

    Dulaglutide

    Dulaglutide administered SC

  • Placebo comparator

    Placebo

    Placebo administered SC

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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(3)

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

    Time frame · Baseline through study completion (12 weeks)

    Registry description

    PK: AUC of LY3437943

  2. PK: Maximum Concentration (Cmax) of LY3437943

    Time frame · Baseline through study completion (12 weeks)

    Registry description

    PK: Cmax of LY3437943

  3. Change from Baseline in Mean Daily Plasma Glucose (PG)

    Time frame · Baseline through Day 80

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

13 results

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.

Urva et al. 2022Lancet (London, England)cited by 150

PMID 36354040DOI 10.1016/s0140-6736(22)02033-5PUB-36354040

Full text at the publisher13 results
Publisher pageSee results (13)

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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