A Study of LY3502970 in Healthy Participants

NCT03929744 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17416J2A-MC-GZGA
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

The main purposes of this study are to determine:

• The safety of LY3502970 and any side effects that might be associated with it.
• How much LY3502970 gets into the bloodstream and how long it takes the body to get rid of it. This study has 5 parts (A, B, C, D, and E). Parts A and D involve a single dose of LY3502970 and will last about 15 days. Part B and E involve multiple doses of LY3502970 and will last about 4 weeks. Part C involves two single doses of LY3502970 and will last about 29 days. Each participant will enroll in only one part. Screening must be completed within 28 days before study start. This study is for research purposes only, and is not intended to treat any medical condition.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline up to Day 42

Secondary Outcomes (3)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970

  Predose up to 96 hours postdose

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

  Predose up to 96 hours postdose

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

  Predose up to 96 hours postdose

Study Arms (9)

LY3502970 (Part A)

EXPERIMENTAL

Single dose of LY3502970 administered orally.

Drug: LY3502970

Placebo (Part A)

PLACEBO COMPARATOR

Single dose of placebo administered orally.

Drug: Placebo

LY3502970 (Part B)

EXPERIMENTAL

Multiple doses of LY3502970 administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.

Drug: LY3502970; Drug: Atorvastatin; Drug: Simvastatin; Drug: Midazolam

Placebo (Part B)

PLACEBO COMPARATOR

Multiple doses of placebo administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.

Drug: Placebo; Drug: Atorvastatin; Drug: Simvastatin; Drug: Midazolam

LY3502970 (Part C)

EXPERIMENTAL

Single dose of LY3502970 administered orally in each of two study periods.

Drug: LY3502970

LY3502970 (Part D)

EXPERIMENTAL

Single dose of LY3502970 administered orally.

Drug: LY3502970

Placebo (Part D)

PLACEBO COMPARATOR

Single dose of placebo administered orally.

Drug: Placebo

LY3502970 Formulation 1 (Part E)

EXPERIMENTAL

Multiple doses of LY3502970 - formulation 1 administered orally.

Drug: LY3502970

LY3502970 Formulation 2 (Part E)

EXPERIMENTAL

Multiple doses of LY3502970 - formulation 2 administered orally.

Drug: LY3502970

Interventions

LY3502970 DRUG

Administered orally.

LY3502970 (Part A); LY3502970 (Part B); LY3502970 (Part C); LY3502970 (Part D); LY3502970 Formulation 1 (Part E); LY3502970 Formulation 2 (Part E)

Placebo DRUG

Administered orally.

Placebo (Part A); Placebo (Part B); Placebo (Part D)

Atorvastatin DRUG

Administered orally.

LY3502970 (Part B); Placebo (Part B)

Simvastatin DRUG

Administered orally.

LY3502970 (Part B); Placebo (Part B)

Midazolam DRUG

Administered orally.

LY3502970 (Part B); Placebo (Part B)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or females, as determined by medical history
• Have safety laboratory results within normal reference ranges

You may not qualify if:

• Have known allergies to LY3502970, glucagon-like peptide-1 (GLP-1) analogs, related compounds
• Abnormal electrocardiogram (ECG) at screening
• Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Dallas

Dallas, Texas, 75247, United States

Location

Related Publications (1)

• Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24.

  PMID: 38402332 DERIVED

MeSH Terms

Interventions

orforglipron; Atorvastatin; Simvastatin; Midazolam

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part C is a crossover design.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: June 12, 2019
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)