Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3502970 · 17 trials · 9 indications
Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Country + Baseline HbA1c Group (\<=8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Absolute bioavailability of LY3502970, expressed in percentage, was estimated using the AUC(0-∞) values from each individual participant based on IV dosed \[14C\]-LY3502970 compared to oral dosed LY3502970, using formula: \[AUC0-∞(oral) x Dose (IV) divided by AUC0-∞(IV) x Dose (oral)\] x100. The sampling time points from pre-oral dose through 186 hours post-IV dose were used to assess this outcome.
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
PK: (AUC0-∞) of LY3502970 is reported.
PK: AUC0-tlast of LY3502970 is reported.
PK: Cmax of LY3502970 is reported.
PK: AUC (0-∞) of LY3502970.
PK: AUC\[0-24\] of LY3502970 in fasted state
PK: Cmax of LY3502970 in fasted state
PK: Tmax of LY3502970 in fasted state
PK: AUC of LY3502970
PK: AUC(0-∞) of LY3502970 is reported.
PK: AUC(0-tlast) of LY3502970 is reported.
PK: Cmax of LY3502970 in Formulation 1 and Formulation 2
PK:(AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2
PK: Tmax of LY3502970 in Formulation 1 and Formulation 2
PK: AUC0-24 of LY3502970.
PK: Tmax of LY3502970
Part A: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).
Part A: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).
Part A: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).
Part B: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.
Part B: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.
Part B: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.
Feces excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Feces samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome.
Urinary excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Urine samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome.
An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations based on medical judgement. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
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.
| Arm | Type | Description |
|---|---|---|
| 12 milligram (mg) LY3502970 | EXPERIMENTAL | Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks. |
| 24 mg LY3502970 | EXPERIMENTAL | Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks. |
| 36 mg-1 LY3502970 | EXPERIMENTAL | Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks. |
| 36 mg-2 LY3502970 | EXPERIMENTAL | Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks. |
| 45 mg-1 LY3502970 | EXPERIMENTAL | Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks. |
| 45 mg-2 LY3502970 | EXPERIMENTAL | Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo administered orally once daily until 36 weeks. |
| 3 milligrams (mg) LY3502970 | EXPERIMENTAL | Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD). |
| 12 mg LY3502970 | EXPERIMENTAL | Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD. |
| 36 mg LY3502970 - 1 | EXPERIMENTAL | Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD. |
| 36 mg LY3502970 - 2 | EXPERIMENTAL | Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD. |
| 45 mg LY3502970 - 1 | EXPERIMENTAL | Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD. |
| 45 mg LY3502970 - 2 | EXPERIMENTAL | Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD. |
| 1.5 mg Dulaglutide | ACTIVE_COMPARATOR | Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW). |
| LY3502970 + [14C]-LY3502970 | EXPERIMENTAL | Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970 radiolabeled with carbon-14 (\[14C\]-LY3502970) containing approximately 800 nanocurie (nCi) radioactivity. |
| LY3502970 (Cohort 1) | EXPERIMENTAL | Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 milligram (mg), 3 mg, 6 mg and then 12 mg LY3502970 administered orally once daily (QD) from Day 1 for 16 weeks. |
| LY3502970 (Cohort 2) | EXPERIMENTAL | Participants received LY3502970 with dose escalation every 4 weeks, starting from 1 mg, 3 mg, 6 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD from Day 1 for 24 weeks. |
| LY3502970 (Normal Renal Function) | EXPERIMENTAL | A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function \[defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)\] on day 1. |
| LY3502970 (Severe Renal Impairment) | EXPERIMENTAL | A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\] on day 1. |
| LY3502970 (End-Stage Renal Disease) | EXPERIMENTAL | A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\] on day 1. |
| 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. |
| 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. |
| 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. |
| 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. |
| Part A: LY3502970 (Periods 1 to 11) | EXPERIMENTAL | Participants received a once daily (QD) oral dose of LY3502970 in the tablet or capsule formulation, depending on the period of the study, throughout Periods 1 to 11 as follows: * Period 1 (Day 1-7): 0.8 milligram (mg) LY3502970 tablet (fasted state) * Period 2 (Day 8-14): 2 mg LY3502970 capsule (fasted state) * Period 3 (Day 15-21): 2.5 mg LY3502970 tablet (fasted state) * Period 4 (Day 22-28): 5 mg LY3502970 tablet (fasted state) * Period 5 (Day 29-35): 8 mg LY3502970 capsule (fasted state) * Period 6 (Day 36-42): 10 mg LY3502970 tablet (fasted state) * Period 7 (Day 43-49): 16 mg LY3502970 capsule (fasted state) * Period 8 (Day 50-56): 20 mg LY3502970 tablet (fasted state) * Period 9 (Day 57-63): 36 mg LY3502970 capsule (fasted state) * Period 10 (Day 64-70): 36 mg LY3502970 capsule or 37.5 mg LY3502970 tablet (fed state) * Period 11 (Day 71-77): 37.5 mg LY3502970 tablet (fasted state) |
| Part B: 45 mg LY3502970 / 60 mg LY3502970 (Periods 12 to 13) | EXPERIMENTAL | Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 45 mg LY3502970 tablet (fasted state) * Period 13 (Day 85-91): 60 mg LY3502970 tablet (fasted state) |
| Part B: 35 mg LY3502970 / 35 mg LY3502970 (Periods 12 to 13) | EXPERIMENTAL | Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 35 mg LY3502970 tablet (fasted state) * Period 13 (Day 85-91): 35 mg LY3502970 tablet (fasted state) |
| Part B: 36 mg LY3502970 DF / 36 mg LY3502970 EPB (Periods 12 to 13) | EXPERIMENTAL | Participants after completion of Part A (Periods 1-11), in Part B received a QD oral dose of LY3502970 as follows: * Period 12 (Day 78-84): 36 mg LY3502970 dual-fill (DF) capsule (fasted state) * Period 13 (Day 85-91): 36 mg LY3502970 extemporaneously prepared blended (EPB) capsule (fasted state) |
| Midazolam + LY3502970 | EXPERIMENTAL | Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1 followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1. |
| Cyclosporine + Midazolam + LY3502970 | EXPERIMENTAL | Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20. |
| 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. |
| 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 |
| LY3502970 Cohort 1 | EXPERIMENTAL | Participants received oral doses of 2 milligrams (mg) LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 once daily (QD). |
| LY3502970 Cohort 2 | EXPERIMENTAL | Participants received oral doses of 1 mg LY3502970 from days 1-7, 2 mg LY3502970 from days 8-21 and 3 mg LY3502970 from days 22-28 QD. |
| LY3502970 Cohort 3 | EXPERIMENTAL | Participants received oral doses of 1 mg LY3502970 from days 1-14, 2 mg LY3502970 from days 15-21 and 3 mg LY3502970 from days 22-28 QD. |
| 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 |
| 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. |
| 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. |
| LY3502970 (Part A) | EXPERIMENTAL | Participants received single doses of LY3502970 administered orally. |
| LY3502970 (Part B) | EXPERIMENTAL | Participants received multiple doses of LY3502970 administered orally. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Participants received placebo administered orally. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Participants received placebo administered orally. |
| 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. |
| 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. |
| 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. |
| Part A | EXPERIMENTAL | * Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 milligrams (mg), increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19. * Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule once daily (QD) * Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2). |
| Part B | EXPERIMENTAL | * Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19. * Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 prototype 2 tablet QD. * Test Phase 1/Fed state (Day 25 to Day 30): During this phase, participants were administered 16 mg of LY3502970 prototype 2 tablet QD. * Test Phase 2/Fasted state (Day 31 to Day 36): During this phase, participants were administered a PPI 40 mg Esomeprazole tablet first, followed by 16 mg of LY3502970 prototype 2 tablet QD. The PPI was administered to elevate gastric pH (potential of hydrogen), and PK (pharmacokinetic) parameters were evaluated under these elevated gastric pH conditions |
| 3mg [¹⁴C]-LY3502970 | EXPERIMENTAL | Participants received a single oral dose of 3 milligrams (mg) of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 microcuries (µCi) of radioactivity on Day 1. |
| LY3502970 | EXPERIMENTAL | 3, 6, 9, 12, 15, 21, 27, 36 and 45 milligrams (mg) LY3502970 administered orally. |
| Part A 0.3 mg LY3502970 | EXPERIMENTAL | Participants received a single oral dose of 0.3 milligram (mg) LY3502970. |
| Part A 1 mg LY3502970 | EXPERIMENTAL | Participants received a single oral dose of 1 mg LY3502970. |
| Part A 3 mg LY3502970 | EXPERIMENTAL | Participants received a single oral dose of 3 mg LY3502970. |
| Part A 6 mg LY3502970 | EXPERIMENTAL | Participants received a single oral dose of 6 mg LY3502970. |
| Part A Placebo | PLACEBO_COMPARATOR | Participants received a single oral dose of Placebo. |
| Part B Placebo | PLACEBO_COMPARATOR | Participants received oral doses of placebo once daily for 4 weeks. |
| Part B: 2 mg LY3502970 (Cohort G) | EXPERIMENTAL | Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| LY3502970 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Dulaglutide | DRUG | Administered subcutaneously |
| [14C]-LY3502970 | DRUG | Administered IV |
| Midazolam | DRUG | Administered orally. |
| Cyclosporine | DRUG | Administered orally. |
| Clarithromycin | DRUG | Administered orally. |
| Esomeprazole | DRUG | Administered orally. |
| [¹⁴C]-LY3502970 | DRUG | Administered orally. |
| Atorvastatin | DRUG | Administered orally. |
| Simvastatin | DRUG | Administered orally. |
Inclusion Criteria: * Have a body mass index (BMI) of ≥30-kilogram square meter (kg/m²) * Have a BMI ≥27 kg/m² and \<30 kg/m² with at least 1 of the following weight-related comorbidities eg; \[Have hypertension, or dyslipidemia, cardiovascular disease\] * Have had a stable body weight for the 3 mo...
Top 20 of 32 competitors
LY3502970 is an investigational small molecule being developed for obesity, type 2 diabetes, and overweight. It is also studied in healthy participants and those with renal insufficiency. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
LY3502970 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical trials for metabolic conditions.
LY3502970 is in Phase 1 clinical development. All 11 trials involving the drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not received regulatory approval.
LY3502970 has completed multiple Phase 1 trials, including NCT05051566 and NCT05110794 in healthy participants, NCT05313802 in healthy overweight and obese participants, and NCT05469126, a drug interaction study with clarithromycin. All trials are completed.
LY3502970 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. All completed trials are early-stage studies in healthy participants and those with metabolic conditions, and the drug has not yet progressed to later-stage trials or approval.