HealthyPhase 1NCT05341089
A Study of Two Different Formulations 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.
Trial summary
The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period. 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
- 39 participants
- Where
- 1 siteSingapore
- Study dates
- 17 May 2022to 1 Sep 2022
- Phase
- Phase 1
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 who have a hemoglobin level of at least 11.4 grams per deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
- Participants with a body weight of at least 45 kilograms (kg) and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²)
- 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 any abnormality in the 12-lead electrocardiogram (ECG) at screening
- Participants who have an abnormal blood pressure, pulse rate, or both, which are deemed to be clinically significant by the investigator, at screening
- Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
- Participants who have used or intend to use over-the-counter or prescription medication including herbal medications or traditional medications within 14 days prior to dosing
- Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies, or both. 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, or both. 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, or all. A negative test within 6 months of screening would not need to be repeated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Multiple-Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of 2 Different Formulations of LY3502970 in Healthy Participants
The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period.
- Conditions
- Healthy
- Being tested
- LY3502970
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3502970Drug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 2 mg/4mg/8mg LY3502970 - Dose Titration Period | Experimental | Participants received escalating oral doses of LY3502970 according to the following dosing schedule:
* Days 1-7: 2 milligrams (mg) once daily (QD)
* Days 8-14: 4 mg QD
* Days 15-21: 8 mg QD Receives: Drug: LY3502970 |
| 16 mg LY3502970 (Formulation 1/Formulation 2) - Test Period | Experimental | Participants received 16 mg LY3502970 Formulation 1 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 2 orally QD from Days 29-35 in test period 2. Receives: Drug: LY3502970 |
| 16 mg LY3502970 (Formulation 2/Formulation 1) - Test Period | Experimental | Participants received 16 mg LY3502970 Formulation 2 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 1 orally QD from Days 29-35 in test period 2. Receives: Drug: LY3502970 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2
PK: Cmax of LY3502970 in Formulation 1 and Formulation 2
Measured: Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2
PK:(AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2
Measured: Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2
PK: Tmax of LY3502970 in Formulation 1 and Formulation 2
Measured: Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start17 May 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341089
- Sponsor's protocol ID
- 17785
- Other IDs
- J2A-MC-GZGH
- Status last verified
- 15 Apr 2026
- First submitted
- 18 Apr 2022
- 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