HealthyPhase 1NCT05469126

A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants

A Phase 1 study testing LY3502970 and Clarithromycin 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 clarithromycin in healthy participants. This study will last up to approximately 85 days for each participant. 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?: LY3502970 and Clarithromycin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteSingapore
Study dates: 1 Aug 2022to 3 Nov 2022
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 Clarithromycin on the Pharmacokinetics of LY3502970 in Healthy Participants

Conditions: Healthy
Being tested: LY3502970, Clarithromycin

What participants receive

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

LY3502970Drug
Administered orally.
ClarithromycinDrug
Administered orally.

Study groups in NCT05469126
Study group	Role	What they receive
LY3502970 alone (Period 1)	Experimental	Participants received a single 3 milligram (mg) dose of LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Receives: Drug: LY3502970
Clarithromycin + LY3502970 (Period 2)	Experimental	Participants received below: Day 15 to 31: 500 mg of clarithromycin administered orally every 12 hours (Q12H). Day 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally. Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later Receives: Drug: LY3502970; Drug: Clarithromycin

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) From Time Zero to Infinity AUC(0-∞) of LY3502970
PK: AUC(0-∞) of LY3502970 is reported.
Measured: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose
PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of LY3502970
PK: AUC(0-tlast) of LY3502970 is reported.
Measured: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose
PK: Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970 is reported.
Measured: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose

Timeline

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

1 Aug 20223 Nov 2022

First posted21 Jul 2022
Study start1 Aug 2022
Primary completion3 Nov 2022
Study completion3 Nov 2022

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: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05469126
Sponsor's protocol ID: 18507
Other IDs: J2A-MC-GZGM
Status last verified: 15 Apr 2026
First submitted: 20 Jul 2022
Last updated: 27 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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Study at a glance

From the registry record, last updated by the sponsor on 27 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 Clarithromycin on the Pharmacokinetics of LY3502970 in Healthy Participants
ClinicalTrials.gov ID: NCT05469126
Acronym / sponsor ID: 18507
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 1 Aug 2022 (actual)
Primary completion: 3 Nov 2022 (actual)
Study completion: 3 Nov 2022 (actual)
First posted: 21 Jul 2022 (actual)
Results: Posted 27 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
LY3502970 alone (Period 1)	Experimental	Drug: LY3502970Participants received a single 3 milligram (mg) dose of LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state for 4 hours after taking the study drug.
Clarithromycin + LY3502970 (Period 2)	Experimental	Drug: LY3502970, Drug: ClarithromycinParticipants received below: Day 15 to 31: 500 mg of clarithromycin administered orally every 12 hours (Q12H). Day 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally. Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later

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
LY3502970Administered orally.	Drug	Clarithromycin + LY3502970 (Period 2), LY3502970 alone (Period 1)
ClarithromycinAdministered orally.	Drug	Clarithromycin + LY3502970 (Period 2)

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970
Time frame: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose
PK: AUC(0-∞) of LY3502970 is reported.
PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of LY3502970
Time frame: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose
PK: AUC(0-tlast) of LY3502970 is reported.
PK: Maximum Observed Concentration (Cmax) of LY3502970
Time frame: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose
PK: Cmax of LY3502970 is reported.

Results and safety

Results posted to the registry on 27 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
3 mg LY3502970 (Day 1) and 500 mg Clarithromycin Q12H + 3 mg LY3502970 (Day 21)	26	21

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970

Time frame: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose. Geometric least squares mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	LY3502970 (Day 1) n = 16	Clarithromycin + LY3502970 (Day 21) n = 12
Value	380 (40)	1380 (31)

LY3502970 (Day 1) vs Clarithromycin + LY3502970 (Day 21): Geometric LS Mean Ratio: 3.54 (90% CI 2.96 to 4.22)

Population analysed: All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an adverse event (AE) of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax).

Primary outcome: PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of LY3502970

Measure	LY3502970 (Day 1) n = 16	Clarithromycin + LY3502970 (Day 21) n = 12
Value	333 (37)	1270 (30)

LY3502970 (Day 1) vs Clarithromycin + LY3502970 (Day 21): Geometric LS Mean Ratio: 3.69 (90% CI 3.19 to 4.28)

Population analysed: All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of tmax.

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

Measure	LY3502970 (Day 1) n = 16	Clarithromycin + LY3502970 (Day 21) n = 12
Value	15.4 (38)	30.4 (30)

LY3502970 (Day 1) vs Clarithromycin + LY3502970 (Day 21): Geometric LS Mean Ratio: 1.88 (90% CI 1.61 to 2.19)

Population analysed: All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of tmax.

Adverse events

Time frame: Baseline up to 43 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3 mg LY3502970	0 of 26 (0%)	23 of 26 (88.5%)	0 of 26
500 mg Clarithromycin Q12H	0 of 21 (0%)	9 of 21 (42.9%)	0 of 21
500 mg Clarithromycin Q12H + 3 mg LY3502970	0 of 21 (0%)	21 of 21 (100%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 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 LY3502970 and Clarithromycin 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 27 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 27 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) From Time Zero to Infinity AUC(0-∞) of LY3502970 (time frame: Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose). The study lists 3 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 NCT05469126.

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 27 May 2026.