AzTrials
AzTrials

HealthyPhase 1NCT03929744

A Study of LY3502970 in Healthy Participants

A Phase 1 study testing LY3502970, Atorvastatin and Simvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY3502970, Atorvastatin and Simvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
133 participants
Where
1 siteUnited States
Study dates
12 Jun 2019to 2 Nov 2020
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Covance Dallas

    Dallas, Texas, 75247

Other trials in United States

About this study

Official title: A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Healthy Subjects

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
Being tested
LY3502970, Placebo, Atorvastatin, Simvastatin, Midazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3502970Drug

    Administered orally.

  • PlaceboDrug

    Administered orally.

  • AtorvastatinDrug

    Administered orally.

  • SimvastatinDrug

    Administered orally.

  • MidazolamDrug

    Administered orally.

Study groups in NCT03929744
Study groupRoleWhat they receive
Part A 0.3 mg LY3502970ExperimentalParticipants received a single oral dose of 0.3 milligram (mg) LY3502970.
Receives: Drug: LY3502970
Part A 1 mg LY3502970ExperimentalParticipants received a single oral dose of 1 mg LY3502970.
Receives: Drug: LY3502970
Part A 3 mg LY3502970ExperimentalParticipants received a single oral dose of 3 mg LY3502970.
Receives: Drug: LY3502970
Part A 6 mg LY3502970ExperimentalParticipants received a single oral dose of 6 mg LY3502970.
Receives: Drug: LY3502970
Part A PlaceboPlacebo comparatorParticipants received a single oral dose of Placebo.
Receives: Drug: Placebo
Part B PlaceboPlacebo comparatorParticipants received oral doses of placebo once daily for 4 weeks.
Receives: Drug: Placebo
Part B: 2 mg LY3502970 (Cohort G)ExperimentalParticipants received oral doses of 2 mg LY3502970 once daily for 4 weeks.
Receives: Drug: LY3502970
Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)ExperimentalParticipants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week.
Receives: Drug: LY3502970
Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)ExperimentalParticipants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week.
Receives: Drug: LY3502970
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort J)ExperimentalParticipants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, midazolam 200 microgram (mcg) was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam.
Receives: Drug: LY3502970; Drug: Atorvastatin; Drug: Midazolam
Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort K)ExperimentalParticipants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970.
Receives: Drug: LY3502970; Drug: Simvastatin
Part C: 3 mg LY3502970 (Fasted/Fed)ExperimentalPart C of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods.
Receives: Drug: LY3502970
Part C: 3 mg LY3502970 (Fed/Fasted)ExperimentalPart C of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods.
Receives: Drug: LY3502970
Part D: 3 mg LY3502970 Prototype FormulationActive comparatorPart D of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.
Receives: Drug: LY3502970
Part D: Placebo Prototype FormulationPlacebo comparatorPart D of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of placebo in a controlled-release prototype formulation.
Receives: Drug: Placebo
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)ExperimentalPart E of the study is exploratory, conducted to study exploratory objectives. Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week.
Receives: Drug: LY3502970
Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)ExperimentalPart E of the study is exploratory, conducted to study exploratory objectives. Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week.
Receives: Drug: LY3502970

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts A and B: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

    An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), 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 subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

    Measured: Baseline through Follow-up (up to Day 42)

Secondary outcomes (9)
  1. Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970

    PK: Cmax of LY3502970

    Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose

  2. Part A: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970

    PK: AUC(0-tlast) of LY3502970

    Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose

  3. Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970

    PK: Tmax of LY3502970

    Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose

  4. Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1

    PK: Cmax of LY3502970

    Measured: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)

  5. Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 28

    PK: Cmax of LY3502970

    Measured: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)

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

    PK: AUC(0-tlast) of LY3502970

    Measured: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)

  7. Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 28

    PK: AUC(0-tlast) of LY3502970

    Measured: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)

  8. Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 1

    PK: Tmax of LY3502970

    Measured: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)

  9. Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 28

    PK: Tmax of LY3502970

    Measured: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2019
  2. Study start12 Jun 2019
  3. Primary completion2 Nov 2020
  4. Study completion2 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Sequential
Model description
Part C is a crossover design.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03929744
Sponsor's protocol ID
17416
Other IDs
J2A-MC-GZGA
Status last verified
Jun 2026
First submitted
25 Apr 2019
Last updated
10 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38402332

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3502970, Atorvastatin and Simvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts A and B: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug (time frame: Baseline through Follow-up (up to Day 42)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03929744, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in