NCT05313802

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2022

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 26, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

April 4, 2022

Last Update Submit

October 17, 2022

Conditions

HealthyObese

Keywords

PharmacokineticsSafety and TolerabilityLY3502970

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Predose up to 42 days

Secondary Outcomes (4)

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970

    Predose up to 29 days postdose

  • PK: Maximum Observed Concentration (Cmax) of LY3502970

    Predose up to 29 days postdose

  • PK: Time to Maximum Observed Concentration (Tmax) of LY3502970

    Predose up to 29 days postdose

  • Pharmacodynamics (PD): Change From Baseline in Body Weight

    Predose through Day 28

Study Arms (3)

LY3502970 (Dose Level 1)

EXPERIMENTAL

LY3502970 administered orally.

Drug: LY3502970

LY3502970 (Dose Level 2)

EXPERIMENTAL

LY3502970 administered orally.

Drug: LY3502970

LY3502970 (Dose Level 3)

EXPERIMENTAL

LY3502970 administered orally.

Drug: LY3502970

Interventions

LY3502970DRUG

Administered orally.

LY3502970 (Dose Level 1)LY3502970 (Dose Level 2)LY3502970 (Dose Level 3)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with stable body weight for at least one month prior to randomization.
  • Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²)
  • Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

You may not qualify if:

  • Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs
  • Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders
  • Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Qps-Mra, Llc

Miami, Florida, 33143, United States

Location

ICON Early Phase Services Lenexa Center

Lenexa, Kansas, 66219, United States

Location

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

orforglipron

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 6, 2022

Study Start

May 26, 2022

Primary Completion

September 9, 2022

Study Completion

September 9, 2022

Last Updated

October 18, 2022

Record last verified: 2022-10-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)