HealthyPhase 1NCT05882032

A Study of LY3502970 in Participants With Impaired and Normal Liver Function

A Phase 1 study testing LY3502970 in people with Healthy and Hepatic Insufficiency, run by Eli Lilly and Company at 4 sites in United States.

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 measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Hepatic Insufficiency
What is being tested?: LY3502970
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 4 sitesUnited States
Study dates: 13 Jun 2023to 18 Nov 2024
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men or women with body weight of at least 45 kilograms and a body mass index of 18.5 to 40.0 kilograms per meter squared (kg/m²).
Both healthy individuals and individuals with hepatic impairment classified as Child-Pugh Score A, B, C that is mild, moderate, or severe impairment, respectively, liver disease can participate who are considered acceptable for participation in this study by the investigator.
Participants must have a diagnosis of chronic hepatic impairment for more than 6 months per physician diagnosis and standard of care practice, with no clinically significant changes within 15 days prior to study intervention administration.
Participants may have mild stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct.
Have acceptable BP and pulse rate, as determined by the investigator at screening.
No significant history of spontaneous or ethanol induced hypoglycemia.

Show all 10Show fewer

Participants with Mild to Severe Hepatic Impairment who have a hemoglobin level of at least 8.5 grams/deciliter.
Participants with both T2DM and Hepatic Impairment have T2DM controlled with diet or exercise alone or on stable doses of anti-diabetic medications metformin or sulfonylureas, for at least 8 weeks prior to screening.
Participants with both T2DM and Hepatic Impairment have a hemoglobin A1c greater than or equal to 5.0% and less than or equal to 11.0% at the screening visit.
Participants with both T2DM and Hepatic Impairment have clinical laboratory test results within normal range or deemed clinically insignificant by the investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable.

Who cannot join

Have significant history of, or current, cardiovascular, respiratory, hepatic (applies to Group 1 only), renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
Have a history or presence of pancreatitis, elevation in serum amylase or lipase (greater than 1.5-fold ULN) or GI disorder or any GI disease, which impacts gastric emptying.
Have any abnormality in the 12-lead ECG at screening.
Have severe atopy or have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions.
Have a history of, or current psychiatric disorders.
Women who are pregnant, intend to become pregnant or are breastfeeding a child are not eligible to participate.
Have taken any glucose-lowering medications other than metformin, sulfonylureas, and insulin, in the past 6 weeks or 5 half-lives (whichever is longer) prior to planned dosing.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Clinical Pharmacology of Miami
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
Texas Liver Institute
San Antonio, Texas, 78215
Pinnacle Clinical Research
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1, Multicenter, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment

Conditions: Healthy, Hepatic Insufficiency
Being tested: LY3502970
Keywords: LY3502970, Pharmacokinetics Hepatic Impairment, GLP-1 Receptor Non-peptide agonist (GLP-1 NPA)
Medical subject headings: Hepatic Insufficiency

What participants receive

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

LY3502970Drug
Administered orally.

Study groups in NCT05882032
Study group	Role	What they receive
1 mg LY3502970 (Control: Normal Hepatic Function)	Experimental	Participants with normal hepatic function received a single 1 milligram (mg) dose of LY3502970 administered orally on Day 1. Receives: Drug: LY3502970
1 mg LY3502970 (Mild Hepatic Impairment)	Experimental	Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. Receives: Drug: LY3502970
1 mg LY3502970 (Moderate Hepatic Impairment)	Experimental	Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. Receives: Drug: LY3502970
1 mg LY3502970 (Severe Hepatic Impairment)	Experimental	Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1. Receives: Drug: LY3502970

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 From Time Zero to Infinity (AUC [0-∞]) of LY3502970
PK: AUC (0-∞) of LY3502970.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970
PK: AUC0-tlast of LY3502970.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
PK: Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1

Timeline

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

13 Jun 202318 Nov 2024

First posted31 May 2023
Study start13 Jun 2023
Primary completion18 Nov 2024
Study completion18 Nov 2024

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: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05882032
Sponsor's protocol ID: 18624
Other IDs: J2A-MC-GZPB
Status last verified: Apr 2026
First submitted: 22 May 2023
Last updated: 27 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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?

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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, Multicenter, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment
ClinicalTrials.gov ID: NCT05882032
Acronym / sponsor ID: 18624
Conditions: Healthy, Hepatic Insufficiency
Keywords: LY3502970, Pharmacokinetics Hepatic Impairment, GLP-1 Receptor Non-peptide agonist (GLP-1 NPA)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 13 Jun 2023 (actual)
Primary completion: 18 Nov 2024 (actual)
Study completion: 18 Nov 2024 (actual)
First posted: 31 May 2023 (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: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
1 mg LY3502970 (Control: Normal Hepatic Function)	Experimental	Drug: LY3502970Participants with normal hepatic function received a single 1 milligram (mg) dose of LY3502970 administered orally on Day 1.
1 mg LY3502970 (Mild Hepatic Impairment)	Experimental	Drug: LY3502970Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
1 mg LY3502970 (Moderate Hepatic Impairment)	Experimental	Drug: LY3502970Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.
1 mg LY3502970 (Severe Hepatic Impairment)	Experimental	Drug: LY3502970Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Men or women with body weight of at least 45 kilograms and a body mass index of 18.5 to 40.0 kilograms per meter squared (kg/m²).
Both healthy individuals and individuals with hepatic impairment classified as Child-Pugh Score A, B, C that is mild, moderate, or severe impairment, respectively, liver disease can participate who are considered acceptable for participation in this study by the investigator.
Participants must have a diagnosis of chronic hepatic impairment for more than 6 months per physician diagnosis and standard of care practice, with no clinically significant changes within 15 days prior to study intervention administration.
Participants may have mild stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct.
Have acceptable BP and pulse rate, as determined by the investigator at screening.

Key exclusion criteria (7 listed)

Have significant history of, or current, cardiovascular, respiratory, hepatic (applies to Group 1 only), renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
Have a history or presence of pancreatitis, elevation in serum amylase or lipase (greater than 1.5-fold ULN) or GI disorder or any GI disease, which impacts gastric emptying.
Have any abnormality in the 12-lead ECG at screening.
Have severe atopy or have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions.
Have a history of, or current psychiatric disorders.

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	1 mg LY3502970 (Control: Normal Hepatic Function), 1 mg LY3502970 (Mild Hepatic Impairment), 1 mg LY3502970 (Moderate Hepatic Impairment), 1 mg LY3502970 (Severe Hepatic Impairment)

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
PK: AUC (0-∞) of LY3502970.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
PK: AUC0-tlast of LY3502970.
PK: Maximum Observed Concentration (Cmax) of LY3502970
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
PK: Cmax of LY3502970.

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
1 mg LY3502970 (Control: Normal Hepatic Function)	11	11
1 mg LY3502970 (Mild Hepatic Impairment)	6	6
1 mg LY3502970 (Moderate Hepatic Impairment)	6	6
1 mg LY3502970 (Severe Hepatic Impairment)	6	6

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

Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram *hour per milliliter (ng*h/mL)

Measure	1 mg LY3502970 (Control: Normal Hepatic Function) n = 10	1 mg LY3502970 (Mild Hepatic Impairment) n = 6	1 mg LY3502970 (Moderate Hepatic Impairment) n = 6	1 mg LY3502970 (Severe Hepatic Impairment) n = 6
Value	130 (26.8)	132 (60.2)	209 (32.6)	611 (84.6)

Population analysed: All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the 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 Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970

Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	1 mg LY3502970 (Control: Normal Hepatic Function) n = 10	1 mg LY3502970 (Mild Hepatic Impairment) n = 6	1 mg LY3502970 (Moderate Hepatic Impairment) n = 6	1 mg LY3502970 (Severe Hepatic Impairment) n = 6
Value	109 (29.1)	112 (64.0)	169 (32.7)	385 (54.7)

Population analysed: All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax).

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

Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	1 mg LY3502970 (Control: Normal Hepatic Function) n = 11	1 mg LY3502970 (Mild Hepatic Impairment) n = 6	1 mg LY3502970 (Moderate Hepatic Impairment) n = 6	1 mg LY3502970 (Severe Hepatic Impairment) n = 6
Value	5.10 (21.0)	5.47 (57.5)	6.12 (43.6)	5.95 (36.1)

Population analysed: All enrolled participants who received at least one dose of LY3502970 and had evaluable PK data for this outcome measure. Participants were excluded from the analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax).

Adverse events

Time frame: Baseline up to end of follow-up (up to 14 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 mg LY3502970 (Control: Normal Hepatic Function)	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
1 mg LY3502970 (Mild Hepatic Impairment)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
1 mg LY3502970 (Moderate Hepatic Impairment)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
1 mg LY3502970 (Severe Hepatic Impairment)	0 of 6 (0%)	0 of 6 (0%)	0 of 6

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.
A Study of LY3502970 in Participants With Impaired and Normal Liver FunctionLink provided by the sponsor.
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

4 sites 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 in people with Healthy and Hepatic Insufficiency, run by Eli Lilly and Company at 4 sites 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 10 inclusion and 7 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 4 sites 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. 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 From Time Zero to Infinity (AUC [0-∞]) of LY3502970 (time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1). 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 NCT05882032.

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.