HealthyPhase 1NCT03929744
A Study of LY3502970 in Healthy Participants
A Phase 1 study testing LY3502970, Atorvastatin and Simvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purposes of this study are to determine: The safety of LY3502970 and any side effects that might be associated with it. How much LY3502970 gets into the bloodstream and how long it takes the body to get rid of it. This study has 5 parts (A, B, C, D, and E). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3502970, Atorvastatin and Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 2 Nov 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or females, as determined by medical history
- Have safety laboratory results within normal reference ranges
Who cannot join
- Have known allergies to LY3502970, glucagon-like peptide-1 (GLP-1) analogs, related compounds
- Abnormal electrocardiogram (ECG) at screening
- Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Healthy Subjects
The main purposes of this study are to determine:
- The safety of LY3502970 and any side effects that might be associated with it.
- How much LY3502970 gets into the bloodstream and how long it takes the body to get rid of it.
This study has 5 parts (A, B, C, D, and E). Parts A and D involve a single dose of LY3502970 and will last about 15 days. Part B and E involve multiple doses of LY3502970 and will last about 4 weeks. Part C involves two single doses of LY3502970 and will last about 29 days. Each participant will enroll in only one part. Screening must be completed within 28 days before study start. This study is for research purposes only, and is not intended to treat any medical condition.
- Conditions
- Healthy
- Being tested
- LY3502970, Placebo, Atorvastatin, Simvastatin, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3502970Drug
Administered orally.
PlaceboDrug
Administered orally.
AtorvastatinDrug
Administered orally.
SimvastatinDrug
Administered orally.
MidazolamDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A 0.3 mg LY3502970 | Experimental | Participants received a single oral dose of 0.3 milligram (mg) LY3502970. Receives: Drug: LY3502970 |
| Part A 1 mg LY3502970 | Experimental | Participants received a single oral dose of 1 mg LY3502970. Receives: Drug: LY3502970 |
| Part A 3 mg LY3502970 | Experimental | Participants received a single oral dose of 3 mg LY3502970. Receives: Drug: LY3502970 |
| Part A 6 mg LY3502970 | Experimental | Participants received a single oral dose of 6 mg LY3502970. Receives: Drug: LY3502970 |
| Part A Placebo | Placebo comparator | Participants received a single oral dose of Placebo. Receives: Drug: Placebo |
| Part B Placebo | Placebo comparator | Participants received oral doses of placebo once daily for 4 weeks. Receives: Drug: Placebo |
| Part B: 2 mg LY3502970 (Cohort G) | Experimental | Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks. Receives: Drug: LY3502970 |
| Part B: 2 / 4 / 6 mg LY3502970 (Cohort H) | Experimental | Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week. Receives: Drug: LY3502970 |
| Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I) | Experimental | Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week. Receives: Drug: LY3502970 |
| Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort J) | Experimental | Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, midazolam 200 microgram (mcg) was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam. Receives: Drug: LY3502970; Drug: Atorvastatin; Drug: Midazolam |
| Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort K) | Experimental | Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970. Receives: Drug: LY3502970; Drug: Simvastatin |
| Part C: 3 mg LY3502970 (Fasted/Fed) | Experimental | Part C of the study is exploratory, conducted to study exploratory objectives.
Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods. Receives: Drug: LY3502970 |
| Part C: 3 mg LY3502970 (Fed/Fasted) | Experimental | Part C of the study is exploratory, conducted to study exploratory objectives.
Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods. Receives: Drug: LY3502970 |
| Part D: 3 mg LY3502970 Prototype Formulation | Active comparator | Part D of the study is exploratory, conducted to study exploratory objectives.
Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation. Receives: Drug: LY3502970 |
| Part D: Placebo Prototype Formulation | Placebo comparator | Part D of the study is exploratory, conducted to study exploratory objectives.
Participants received a single oral dose of placebo in a controlled-release prototype formulation. Receives: Drug: Placebo |
| Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1) | Experimental | Part E of the study is exploratory, conducted to study exploratory objectives.
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week. Receives: Drug: LY3502970 |
| Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2) | Experimental | Part E of the study is exploratory, conducted to study exploratory objectives.
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week. Receives: Drug: LY3502970 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A and B: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported. An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Measured: Baseline through Follow-up (up to Day 42)
Secondary outcomes (9)
Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose
Part A: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970
PK: AUC(0-tlast) of LY3502970
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970
PK: Tmax of LY3502970
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1
PK: Cmax of LY3502970
Measured: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 28
PK: Cmax of LY3502970
Measured: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)
Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1
PK: AUC(0-tlast) of LY3502970
Measured: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)
Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 28
PK: AUC(0-tlast) of LY3502970
Measured: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 1
PK: Tmax of LY3502970
Measured: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 28
PK: Tmax of LY3502970
Measured: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start12 Jun 2019
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
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
- Sequential
- Model description
- Part C is a crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 133 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
- NCT03929744
- Sponsor's protocol ID
- 17416
- Other IDs
- J2A-MC-GZGA
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2019
- Last updated
- 10 Jul 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