Current partner codePEPTIDESDE
NCT04823208·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

64

Locations

4

Results

Not posted

Publications

0

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 Japanese participants with type 2 diabetes mellitus. 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 or placebo given just under the skin. For each participant, the study will last up to 5 months, inclusive of screening and will include 16 visits to the study center.

Interventions

Treatment arms and agents.

DRUG

LY3437943

Administered SC

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Mar 30, 2021

  2. Study start

    May 24, 2021

  3. Primary completion

    Jun 23, 2022

  4. Study completion

    Jun 23, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Aug 22, 2022

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): Maximum Concentration (Cmax) of LY3437943

Time frame · Predose on Day 1 through Day 81

PK: Cmax of LY3437943

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

Time frame · Predose on Day 1 through Day 81

PK: AUC 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

Change from Baseline in Glycated Hemoglobin (HbA1c)

Time frame · Baseline through Day 78

Change from Baseline in HbA1c

Change from Baseline in Fasting Glucose

Time frame · Baseline through Day 78

Change from Baseline in Fasting Glucose

Change from Baseline in Body Weight

Time frame · Baseline through Day 78

Change from Baseline in Body Weight

Eligibility

Who can take part.

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

Inclusion Criteria: * Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year. * Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at lead-in and screening * Have a body mass index (BMI) within the range 23 to 35 kilograms per square meter (kg/m²), inclusive, and a body weight of at least 54 kilograms (Kg). * Males and females not of childbearing potential Exclusion Criteria: * Have type 1 diabetes mellitus (T1DM) * Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization * Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. * Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of \>500 milligram per deciliter (mg/dL). * 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 3× upper limit of normal (ULN).

Study locations

4 registered sites.

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

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, Japan

P-one clinic

Hachiōji, Tokyo, Japan

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Yokohama Minoru Clinic

Yokohama, Japan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Retatrutide.

Related PeptideStat pages

Put the record in context.

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