HealthyPhase 1NCT05573230

A Drug Interaction Study of Cyclosporine and LY3502970 in Healthy Participants

A Phase 1 study testing Midazolam, LY3502970 and Cyclosporine in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.

Completed

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

Official record

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Trial summary

The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with cyclosporine in healthy participants. The study will also evaluate the safety and tolerability of LY3502970 in healthy participants. Read more about this study

Who is it for?: Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Midazolam, LY3502970 and Cyclosporine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteSingapore
Study dates: 17 Oct 2022to 17 Jan 2023
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 21 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants who are overtly healthy as determined by medical evaluation
Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²)
Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Who cannot join

Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Participants who regularly use known drugs of abuse
Women who are lactating and who are of child-bearing potential
Participants who have known allergies to LY3502970, related compounds, or any components of the formulation

Trial locations and contacts

1 site in 1 country.

Singapore1 site

Lilly Centre for Clinical Pharmacology
Singapore, 138623

Other trials in Singapore

About this study

Official title: A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Cyclosporine on the Pharmacokinetics of LY3502970 in Healthy Participants

Conditions: Healthy
Being tested: Midazolam, LY3502970, Cyclosporine

What participants receive

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

MidazolamDrug
Administered orally.
LY3502970Drug
Administered orally.
CyclosporineDrug
Administered orally.

Study groups in NCT05573230
Study group	Role	What they receive
Midazolam + LY3502970	Experimental	Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1 followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1. Receives: Drug: Midazolam; Drug: LY3502970
Cyclosporine + Midazolam + LY3502970	Experimental	Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20. Receives: Drug: Midazolam; Drug: LY3502970; Drug: Cyclosporine

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
PK: AUC of LY3502970
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose
PK: Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose

Timeline

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

17 Oct 202217 Jan 2023

First posted10 Oct 2022
Study start17 Oct 2022
Primary completion17 Jan 2023
Study completion17 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05573230
Sponsor's protocol ID: 18506
Other IDs: J2A-MC-GZGL
Status last verified: Apr 2026
First submitted: 7 Oct 2022
Last updated: 26 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Cyclosporine on the Pharmacokinetics of LY3502970 in Healthy Participants
ClinicalTrials.gov ID: NCT05573230
Acronym / sponsor ID: 18506
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 17 Oct 2022 (actual)
Primary completion: 17 Jan 2023 (actual)
Study completion: 17 Jan 2023 (actual)
First posted: 10 Oct 2022 (actual)
Results: Posted 26 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Midazolam + LY3502970	Experimental	Drug: Midazolam, Drug: LY3502970Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1 followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1.
Cyclosporine + Midazolam + LY3502970	Experimental	Drug: Midazolam, Drug: LY3502970, Drug: CyclosporinePeriod 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participants who are overtly healthy as determined by medical evaluation
Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²)
Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Key exclusion criteria (4 listed)

Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Participants who regularly use known drugs of abuse
Women who are lactating and who are of child-bearing potential
Participants who have known allergies to LY3502970, related compounds, or any components of the formulation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MidazolamAdministered orally.	Drug	Cyclosporine + Midazolam + LY3502970, Midazolam + LY3502970
LY3502970Administered orally.	Drug	Cyclosporine + Midazolam + LY3502970, Midazolam + LY3502970
CyclosporineAdministered orally.	Drug	Cyclosporine + Midazolam + LY3502970

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose
PK: AUC of LY3502970
PK: Maximum Observed Concentration (Cmax) of LY3502970
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose
PK: Cmax of LY3502970

Results and safety

Results posted to the registry on 26 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Midazolam + Cyclosporine + LY3502970	32	25

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

Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram * hour per milliliter (ng*hr/mL

Measure	LY3502970 (Reference) n = 21	Cyclosporine + LY3502970 (Test) n = 10
Value	332 (39)	857 (51)

LY3502970 (Reference) vs Cyclosporine + LY3502970 (Test): Geometric LS Mean Ratio: 2.55 (90% CI 2.07 to 3.14), Mixed Models Analysis

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: Maximum Observed Concentration (Cmax) of LY3502970

Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	LY3502970 (Reference) n = 21	Cyclosporine + LY3502970 (Test) n = 11
Value	13.9 (48)	18.4 (36)

LY3502970 (Reference) vs Cyclosporine + LY3502970 (Test): Geometric LS Mean Ratio: 1.29 (90% CI 1.00 to 1.66), Mixed Models Analysis

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Adverse events

Time frame: Baseline up to 76 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
200 ug Midazolam	0 of 31 (0%)	4 of 31 (12.9%)	0 of 31
3 mg LY3502970 (Reference)	0 of 31 (0%)	28 of 31 (90.3%)	0 of 31
200 mg Cyclosporine BID + 200 ug Midazolam	0 of 24 (0%)	18 of 24 (75%)	0 of 24
200 mg Cyclosporine BID + 3 mg LY3502970 (Test)	0 of 24 (0%)	22 of 24 (91.7%)	0 of 24
200 mg Cyclosporine	0 of 25 (0%)	20 of 25 (80%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Midazolam, LY3502970 and Cyclosporine in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.

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 4 inclusion and 4 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 26 May 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 Singapore. 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. 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 26 May 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?

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970 (time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose). The study lists 2 primary outcomes in all. 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 NCT05573230.

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 26 May 2026.