Current partner codePEPTIDESDE
NCT05959096·Phase 1·INTERVENTIONAL

A Study of LY3437943 in Healthy Participants With a High Body Mass Index

Status

Completed

Phase

Phase 1

Enrollment

85

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The study is conducted in two parts (Part A and B). The main purpose of this study is to look at the amount of the LY3437943 that gets into the blood stream and how long it takes the body to get rid of it when given subcutaneously (SC, under the skin) in the upper arm and thigh compared to the abdomen in healthy participants with high body mass index (BMI) in Part A. In Part B, the participants receive LY3437943 intravenously (IV, through a vein) where the safety and tolerability of LY3437943 are evaluated and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 157 days and 99 days for Part A and Part B, respectively.

Interventions

Treatment arms and agents.

DRUG

LY3437943

Administered SC

DRUG

LY3437943

Administered IV

Timeline

From registration to results.

  1. First posted

    Jul 25, 2023

  2. Study start

    Jul 18, 2023

  3. Primary completion

    Jul 25, 2024

  4. Study completion

    Jul 25, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Oct 1, 2024

Outcomes

What the study measures.

Primary outcomes

Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943

Time frame · Predose on Day 1 up to 43 days postdose (Part A)

Part A: PK: AUC(0-∞) of LY3437943

Part A: PK: Maximum Concentration (Cmax) of LY3437943

Time frame · Predose on Day 1 up to 43 days postdose (Part A)

Part A: PK: Cmax of LY3437943

Secondary outcomes

Part B: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943

Time frame · Predose on Day 1 up to 71 days postdose (Part B)

Part B: PK: AUC(0-∞) of LY3437943

Part B: PK: Maximum Concentration (Cmax) of LY3437943

Time frame · Predose on Day 1 up to 71 days postdose (Part B)

Part B: PK: Cmax of LY3437943

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
Yes

Inclusion Criteria: * Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures * Body mass index (BMI) between 27.0 and 45.0 kilograms per meter squared (kg/m²), inclusive * Are agreeable to receiving study treatment by injections under the skin or through a vein. Exclusion Criteria: * Have a history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form) * Have a significant history of, or presence of, any of the following disorders capable of significantly altering the absorption, metabolism, or elimination of drugs * Have known allergies to LY3437943, related compounds, or any components of the formulation * Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day. * Is a known user of drugs of abuse

Study locations

1 registered sites.

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

Fortrea Clinical Research Unit

Daytona Beach, Florida, United States

Publications

Results and literature.

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

Primary links

Continue at the source.

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Put the record in context.

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