A Study of LY3537021 in Healthy Participants

NCT ID: NCT05444569

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-08

Study Completion Date

2023-02-24

Brief Summary

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The main purpose of this study is to evaluate the safety and tolerability of LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants. The study will include 2 parts. The study will last up to 16 and 22 weeks for part A and B, respectively which includes a screening period of 6 weeks.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study has two parts. Part A is parallel model and part B is crossover.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3537021 + Liraglutide (Part A)

Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC.

Group Type EXPERIMENTAL

LY3537021

Intervention Type DRUG

Administered SC.

Liraglutide

Intervention Type DRUG

Administered SC.

Liraglutide + Placebo (Part A)

Liraglutide administered SC followed by liraglutide in combination with placebo given SC.

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

Administered SC.

Placebo

Intervention Type DRUG

Administered SC.

LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)

LY3537021 administered SC followed by liraglutide administered SC in treatment period 1.

Placebo administered SC followed by liraglutide administered SC in treatment period 2.

Group Type EXPERIMENTAL

LY3537021

Intervention Type DRUG

Administered SC.

Liraglutide

Intervention Type DRUG

Administered SC.

Placebo

Intervention Type DRUG

Administered SC.

Placebo + Liraglutide & LY3537021 + Liraglutide Part B)

Placebo administered SC followed by liraglutide administered SC in treatment period 1.

LY3537021 administered SC followed by liraglutide administered SC in treatment period 2.

Group Type EXPERIMENTAL

LY3537021

Intervention Type DRUG

Administered SC.

Liraglutide

Intervention Type DRUG

Administered SC.

Placebo

Intervention Type DRUG

Administered SC.

Interventions

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LY3537021

Administered SC.

Intervention Type DRUG

Liraglutide

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants who are overtly healthy as determined through medical evaluation
* Participants with body weight at least 55 kilograms (kg) and body mass index (BMI) of 23.0 to 40.0 kilograms per meter squared (kg/m²)
* Males, or females who are not of childbearing potential.
* Capable of giving signed informed consent form
* Have blood pressure of less than 150/90 millimeters of mercury (mm Hg) and pulse rate of less than 100 beats per minute (bpm) (supine)

Exclusion Criteria

* Have a significant history of current disorders capable of significantly altering the absorption, metabolism or elimination of drugs
* History of malignancy within 5 years prior to screening
* Have evidence of significant active psychiatric disorder(s)
* Have undergone any form of bariatric surgery
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Are females who are lactating
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Lilly Centre for Clinical Pharmacology

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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J2R-MC-YAAC

Identifier Type: OTHER

Identifier Source: secondary_id

18449

Identifier Type: -

Identifier Source: org_study_id

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