A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05841238

Collaborator

(none)

Enrollment

Locations

Arms

4.5

Anticipated Duration (Months)

16.7

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.

Condition or Disease	Intervention/Treatment	Phase
Healthy Obese	Drug: LY3502970	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

Part A open label. Part B double blinded.

Primary Purpose:

Basic Science

Official Title:

A Multiple Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tablet and Capsule Formulations of LY3502970 in Healthy Overweight and Obese Participants

Anticipated Study Start Date :

Apr 27, 2023

Anticipated Primary Completion Date :

Sep 12, 2023

Anticipated Study Completion Date :

Sep 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3502970 (Part A) The multiple doses of LY3502970 administered orally either in tablet or capsule formulations.	Drug: LY3502970 Administered orally.
Experimental: LY3502970 (Part B) The multiple doses of LY3502970 administered orally in tablet formulation.	Drug: LY3502970 Administered orally.

Arm

Intervention/Treatment

Experimental: LY3502970 (Part A)

The multiple doses of LY3502970 administered orally either in tablet or capsule formulations.

Drug: LY3502970

Administered orally.

Experimental: LY3502970 (Part B)

The multiple doses of LY3502970 administered orally in tablet formulation.

Drug: LY3502970

Administered orally.

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 [Predose up to 92 days postdose]
PK: AUC[0-24] of LY3502970
PK: Maximum Observed Concentration (Cmax) of LY3502970 [Predose up to 92 days postdose]
PK: Cmax of LY3502970
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 [Predose up to 92 days postdose]
PK: Tmax of LY3502970

Secondary Outcome Measures

PK: AUC[0-24] of LY3502970 in fed state [Predose up to 92 days postdose]
PK: AUC[0-24] of LY3502970 in fed state
PK: Cmax of LY3502970 in fed state [Predose up to 92 days postdose]
PK: Cmax of LY3502970 in fed state
PK: Tmax of LY3502970 in fed state [Predose up to 92 days postdose]
PK: Tmax of LY3502970 in fed state

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female participants who are overtly healthy as determined by medical evaluation
Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more
Participants with a stable body weight, with 5% or less body weight gain or loss

Exclusion Criteria:

Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL)
Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
Have known clinically significant gastric emptying abnormality
Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer
Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug
Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LabCorp CRU, Inc.	Daytona Beach	Florida	United States	32117
2	Labcorp Clinical Research LP	Dallas	Texas	United States	75247
3	LabCorp CRU, Inc.	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05841238

Other Study ID Numbers:

18527
J2A-MC-GZGN

First Posted:

May 3, 2023

Last Update Posted:

May 3, 2023

Last Verified:

Apr 15, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of May 3, 2023