HealthyPhase 1NCT05110794

A Multiple-Dose Study of LY3502970 in Healthy Participants

A Phase 1 study testing LY3502970 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.

Trial summary

The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states. The study will also evaluate the safety and tolerability of LY3502970 in these 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?: LY3502970
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteSingapore
Study dates: 5 Nov 2021to 10 Feb 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

Are overtly healthy as determined by medical evaluation.
Participants with body weight of 45 kilograms (kg) or more and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²).

Who cannot join

Participants who have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator at screening.
Participants who used or intend to use over-the-counter (OTC) or prescription medication and/or herbal/vitamin/traditional medicines or mineral supplements that may affect the safety or objectives of the study, within 14 days prior to dosing and for the duration of the study. Paracetamol and Covid-19 vaccinations are permitted.
Participants who are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. A negative test within 6 months of screening would not need to be repeated.
Participants who show evidence of hepatitis C and/or positive hepatitis C antibody. A negative test within 6 months of screening would not need to be repeated.
Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody. A negative test within 6 months of screening would not need to be repeated.

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 Multiple Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of LY3502970 in Fed and Fasted Healthy Participants

Conditions: Healthy
Being tested: LY3502970
Keywords: Food, Food Effect

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 NCT05110794
Study group	Role	What they receive
LY3502970 Titration	Experimental	Dose Titration Period: Participants received increasing doses of LY3502970 administered orally every 7 days on Day 1 to Day 21. Day 1 to Day 8: 2 milligram (mg) LY3502970 every day (QD), Day 8 to Day 15: 4 mg LY3502970 QD, Day 15 to Day 21: 8 mg LY3502970 QD, Participants were randomized to Fasted state or Fed state sequence on Day 22. Receives: Drug: LY3502970
LY3502970 (Fasted/Fed)	Experimental	Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fasted state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fed state. Receives: Drug: LY3502970
LY3502970 (Fed/Fasted)	Experimental	Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fed state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fasted state. Receives: Drug: LY3502970

What is being measured

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

PK: Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970.
Measured: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970
PK: AUC0-24 of LY3502970.
Measured: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
Time to Maximum Observed Concentration (Tmax) of LY3502970
PK: Tmax of LY3502970
Measured: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)

Timeline

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

5 Nov 202110 Feb 2022

First posted8 Nov 2021
Study start5 Nov 2021
Primary completion10 Feb 2022
Study completion10 Feb 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.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05110794
Sponsor's protocol ID: 18277
Other IDs: J2A-MC-GZGJ
Status last verified: 15 Apr 2026
First submitted: 28 Oct 2021
Last updated: 26 May 2026
Results posted: Yes, on ClinicalTrials.gov
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

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

Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingObservational study
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Immunosuppression, Periodontal Disease
RecruitingObservational study
Adaptive Optics Retinal Imaging
Eye Diseases, Healthy Volunteers
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome

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 Multiple Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of LY3502970 in Fed and Fasted Healthy Participants
ClinicalTrials.gov ID: NCT05110794
Acronym / sponsor ID: 18277
Conditions: Healthy
Keywords: Food, Food Effect
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 5 Nov 2021 (actual)
Primary completion: 10 Feb 2022 (actual)
Study completion: 10 Feb 2022 (actual)
First posted: 8 Nov 2021 (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: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
LY3502970 Titration	Experimental	Drug: LY3502970Dose Titration Period: Participants received increasing doses of LY3502970 administered orally every 7 days on Day 1 to Day 21. Day 1 to Day 8: 2 milligram (mg) LY3502970 every day (QD), Day 8 to Day 15: 4 mg LY3502970 QD, Day 15 to Day 21: 8 mg LY3502970 QD, Participants were randomized to Fasted state or Fed state sequence on Day 22.
LY3502970 (Fasted/Fed)	Experimental	Drug: LY3502970Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fasted state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fed state.
LY3502970 (Fed/Fasted)	Experimental	Drug: LY3502970Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fed state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fasted state.

Who may qualify

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

Key inclusion criteria (2 listed)

Are overtly healthy as determined by medical evaluation.
Participants with body weight of 45 kilograms (kg) or more and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²).

Key exclusion criteria (6 listed)

Participants who have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator at screening.
Participants who used or intend to use over-the-counter (OTC) or prescription medication and/or herbal/vitamin/traditional medicines or mineral supplements that may affect the safety or objectives of the study, within 14 days prior to dosing and for the duration of the study. Paracetamol and Covid-19 vaccinations are permitted.
Participants who are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. A negative test within 6 months of screening would not need to be repeated.
Participants who show evidence of hepatitis C and/or positive hepatitis C antibody. A negative test within 6 months of screening would not need to be repeated.

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	LY3502970 (Fasted/Fed), LY3502970 (Fed/Fasted), LY3502970 Titration

Primary outcome

PK: Maximum Observed Concentration (Cmax) of LY3502970
Time frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
PK: Cmax of LY3502970.
PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970
Time frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
PK: AUC0-24 of LY3502970.
Time to Maximum Observed Concentration (Tmax) of LY3502970
Time frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)
PK: Tmax 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
2 Milligram (mg)/4 mg/8 mg LY3502970	34	29
16 mg LY3502970 (Fasted/Fed)	0	0
16 mg LY3502970 (Fed/Fasted)	0	0

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

Time frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2). Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	16 mg LY3502970 (Fasted) n = 26	16 mg LY3502970 (Fed) n = 25
Value	80.5 (64)	67.5 (40)

Population analysed: All participants who received LY3502970 in fed and fasted state and had evaluable PK samples, per protocol.

Primary outcome: PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970

Time frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2). Geometric mean (Geometric Coefficient of Variation). Unit: ng*hour(h)/mL

Measure	16 mg LY3502970 (Fasted) n = 26	16 mg LY3502970 (Fed) n = 25
Value	1200 (58)	1050 (40)

Population analysed: All participants who received LY3502970 in fed and fasted state and had evaluable PK samples, per protocol.

Primary outcome: Time to Maximum Observed Concentration (Tmax) of LY3502970

Time frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2). Median (Full Range). Unit: hour

Measure	16 mg LY3502970 (Fasted) n = 26	16 mg LY3502970 (Fed) n = 25
Value	8.0 (4.00 to 16.00)	8.00 (4.00 to 24.00)

Population analysed: All participants who received LY3502970 in fed and fasted state and had evaluable PK samples, per protocol.

Adverse events

Time frame: Baseline up to Day 49. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2 Milligram (mg) LY3502970 QD	0 of 33 (0%)	27 of 33 (81.8%)	0 of 33
4 mg LY3502970 QD	0 of 30 (0%)	15 of 30 (50%)	0 of 30
8 mg LY3502970 QD	0 of 30 (0%)	13 of 30 (43.3%)	0 of 30
16 mg LY3502970 QD (Fasted)	0 of 28 (0%)	18 of 28 (64.3%)	0 of 28
16 mg LY3502970 QD (Fed)	0 of 27 (0%)	12 of 27 (44.4%)	0 of 27

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.
Derived from this study: PubMed 38402332Ma 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.
Individual participant dataSharing planned: No

Related trials for Healthy

Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingObservational study
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Immunosuppression, Periodontal Disease
RecruitingObservational study
Adaptive Optics Retinal Imaging
Eye Diseases, Healthy Volunteers
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome

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 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 2 inclusion and 6 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?

PK: Maximum Observed Concentration (Cmax) of LY3502970 (time frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2)). 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 NCT05110794, 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 26 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.