Trial Outcomes & Findings for A Study of Two Different Formulations of LY3502970 in Healthy Participants (NCT NCT05341089)

NCT ID: NCT05341089

Last Updated: 2026-05-27

Results Overview

PK: Cmax of LY3502970 in Formulation 1 and Formulation 2

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

39 participants

Primary outcome timeframe

Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

Results posted on

2026-05-27

Participant Flow

Participant milestones

Participant milestones
Measure
2 mg/4mg/8mg LY3502970 - Dose Titration Period
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
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
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.
Dose Titration Period
STARTED
39
0
0
Dose Titration Period
Received at Least One Dose of LY3502970
38
0
0
Dose Titration Period
COMPLETED
34
0
0
Dose Titration Period
NOT COMPLETED
5
0
0
Test Period 1
STARTED
0
17
17
Test Period 1
Received at Least One Dose of LY3502970
0
17
17
Test Period 1
COMPLETED
0
17
16
Test Period 1
NOT COMPLETED
0
0
1
Test Period 2
STARTED
0
17
16
Test Period 2
Received at Least One Dose of LY3502970
0
17
16
Test Period 2
COMPLETED
0
17
15
Test Period 2
NOT COMPLETED
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
2 mg/4mg/8mg LY3502970 - Dose Titration Period
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
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
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.
Dose Titration Period
Adverse Event
4
0
0
Dose Titration Period
Physician Decision
1
0
0
Test Period 1
Adverse Event
0
0
1
Test Period 2
Withdrawal by Subject
0
0
1

Baseline Characteristics

A Study of Two Different Formulations of LY3502970 in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
2 mg/4mg/8mg LY3502970 - Dose Titration Period
n=38 Participants
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
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=51 Participants
Region of Enrollment
Singapore
38 Participants
n=51 Participants
Age, Continuous
40.4 years
STANDARD_DEVIATION 10.5 • n=51 Participants
Sex: Female, Male
Female
4 Participants
n=51 Participants
Sex: Female, Male
Male
34 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
38 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=51 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=51 Participants
Race (NIH/OMB)
Asian
38 Participants
n=51 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=51 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=51 Participants
Race (NIH/OMB)
White
0 Participants
n=51 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=51 Participants

PRIMARY outcome

Timeframe: Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

Population: The pharmacokinetic population consisted of participants from the test period who received at least one dose of LY3502970 and had evaluable PK samples.

PK: Cmax of LY3502970 in Formulation 1 and Formulation 2

Outcome measures

Outcome measures
Measure
16 mg LY3502970 (Formulation 1)
n=32 Participants
Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 1) were included in this arm.
16 mg LY3502970 (Formulation 2)
n=33 Participants
Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2
86.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40
86.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 43

PRIMARY outcome

Timeframe: Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

Population: The pharmacokinetic population consisted of participants from the test period who received at least one dose of LY3502970 and had evaluable PK samples.

PK:(AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2

Outcome measures

Outcome measures
Measure
16 mg LY3502970 (Formulation 1)
n=32 Participants
Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 1) were included in this arm.
16 mg LY3502970 (Formulation 2)
n=33 Participants
Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm.
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
1260 Nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 38
1240 Nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 40

PRIMARY outcome

Timeframe: Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose

Population: The pharmacokinetic population consisted of participants from the test period who received at least one dose of LY3502970 and had evaluable PK samples.

PK: Tmax of LY3502970 in Formulation 1 and Formulation 2

Outcome measures

Outcome measures
Measure
16 mg LY3502970 (Formulation 1)
n=32 Participants
Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 1) were included in this arm.
16 mg LY3502970 (Formulation 2)
n=33 Participants
Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm.
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2
6.00 Hours (h)
Interval 4.0 to 23.92
6.00 Hours (h)
Interval 2.0 to 12.0

Adverse Events

2 mg LY3502970 - Dose Titration Period

Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths

4 mg LY3502970 - Dose Titration Period

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

8 mg LY3502970 - Dose Titration Period

Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths

16 mg LY3502970 (Formulation 1)

Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths

16 mg LY3502970 (Formulation 2)

Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
2 mg LY3502970 - Dose Titration Period
n=38 participants at risk
Participants from the dose titration period who received 2 mg LY3502970 were included in this arm.
4 mg LY3502970 - Dose Titration Period
n=37 participants at risk
Participants from the dose titration period who received 4 mg LY3502970 were included in this arm.
8 mg LY3502970 - Dose Titration Period
n=34 participants at risk
Participants from the dose titration period who received 8 mg LY3502970 were included in this arm.
16 mg LY3502970 (Formulation 1)
n=33 participants at risk
Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 1) were included in this arm.
16 mg LY3502970 (Formulation 2)
n=34 participants at risk
Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm.
Gastrointestinal disorders
Abdominal discomfort
2.6%
1/38 • Number of events 1 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/37 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/34 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/33 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
5.9%
2/34 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
Gastrointestinal disorders
Abdominal distension
26.3%
10/38 • Number of events 13 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
5.4%
2/37 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
8.8%
3/34 • Number of events 3 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
3.0%
1/33 • Number of events 1 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
2.9%
1/34 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
Gastrointestinal disorders
Constipation
5.3%
2/38 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/37 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
2.9%
1/34 • Number of events 1 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
6.1%
2/33 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/34 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
Gastrointestinal disorders
Diarrhoea
5.3%
2/38 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/37 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
5.9%
2/34 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
9.1%
3/33 • Number of events 8 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
5.9%
2/34 • Number of events 3 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
Gastrointestinal disorders
Nausea
23.7%
9/38 • Number of events 11 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
8.1%
3/37 • Number of events 3 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
17.6%
6/34 • Number of events 6 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
6.1%
2/33 • Number of events 4 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
14.7%
5/34 • Number of events 5 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
Gastrointestinal disorders
Vomiting
34.2%
13/38 • Number of events 38 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
8.1%
3/37 • Number of events 8 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
17.6%
6/34 • Number of events 13 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
18.2%
6/33 • Number of events 13 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
11.8%
4/34 • Number of events 19 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
General disorders
Catheter site bruise
2.6%
1/38 • Number of events 1 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/37 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/34 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
27.3%
9/33 • Number of events 12 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
8.8%
3/34 • Number of events 3 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
General disorders
Catheter site erythema
7.9%
3/38 • Number of events 3 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/37 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/34 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
30.3%
10/33 • Number of events 10 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
29.4%
10/34 • Number of events 12 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
General disorders
Catheter site pain
0.00%
0/38 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/37 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
2.9%
1/34 • Number of events 1 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
12.1%
4/33 • Number of events 4 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
11.8%
4/34 • Number of events 5 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
General disorders
Catheter site phlebitis
0.00%
0/38 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/37 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/34 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/33 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
11.8%
4/34 • Number of events 4 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
General disorders
Catheter site swelling
0.00%
0/38 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/37 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/34 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
6.1%
2/33 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
5.9%
2/34 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
General disorders
Early satiety
5.3%
2/38 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/37 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/34 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/33 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/34 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
Metabolism and nutrition disorders
Decreased appetite
34.2%
13/38 • Number of events 13 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
5.4%
2/37 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
5.9%
2/34 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/33 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
8.8%
3/34 • Number of events 3 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
Nervous system disorders
Dizziness
7.9%
3/38 • Number of events 3 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
5.4%
2/37 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/34 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
6.1%
2/33 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
2.9%
1/34 • Number of events 1 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
Nervous system disorders
Headache
7.9%
3/38 • Number of events 4 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
2.7%
1/37 • Number of events 1 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
17.6%
6/34 • Number of events 8 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
9.1%
3/33 • Number of events 4 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
14.7%
5/34 • Number of events 5 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
Nervous system disorders
Somnolence
0.00%
0/38 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/37 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
2.9%
1/34 • Number of events 1 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
6.1%
2/33 • Number of events 2 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
0.00%
0/34 • From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60