A Study of LY3502970 in Healthy Overweight and Obese Participants

NCT05313802 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18453J2A-MC-GZGK
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy; Obese

Keywords

Pharmacokinetics; Safety and Tolerability; LY3502970

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 TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in one of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.

  Baseline up to Day 42

Secondary Outcomes (7)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1

  Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

• PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1

  Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

• PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 on Day 1

  Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

• PK: AUC[0-tlast] of LY3502970 on Day 28

  Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

• PK: Cmax of LY3502970 on Day 28

  Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)

Study Arms (3)

LY3502970 Cohort 1

EXPERIMENTAL

Participants received oral doses of 2 milligrams (mg) LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 once daily (QD).

Drug: LY3502970

LY3502970 Cohort 2

EXPERIMENTAL

Participants received oral doses of 1 mg LY3502970 from days 1-7, 2 mg LY3502970 from days 8-21 and 3 mg LY3502970 from days 22-28 QD.

Drug: LY3502970

LY3502970 Cohort 3

EXPERIMENTAL

Participants received oral doses of 1 mg LY3502970 from days 1-14, 2 mg LY3502970 from days 15-21 and 3 mg LY3502970 from days 22-28 QD.

Drug: LY3502970

Interventions

LY3502970 DRUG

Administered orally.

LY3502970 Cohort 1; LY3502970 Cohort 2; LY3502970 Cohort 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 %

Sponsors & Collaborators

• Eli Lilly and Company: lead

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)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: May 26, 2026
• Results First Posted: May 26, 2026

Record last verified: 2026-04-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)