Trial Outcomes & Findings for A Study of LY3502970 in Healthy Overweight and Obese Participants (NCT NCT05313802)
NCT ID: NCT05313802
Last Updated: 2026-05-26
Results Overview
A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in one of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, 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 participant or may require intervention to prevent one of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Baseline up to Day 42
Results posted on
2026-05-26
Participant Flow
Participant milestones
| Measure |
LY3502970 Cohort 1
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
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
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
|
Overall Study
Received At Least One Dose of Study Drug
|
24
|
24
|
24
|
|
Overall Study
LY3502970 - 1 mg
|
0
|
24
|
24
|
|
Overall Study
LY3502970 - 2 mg
|
24
|
24
|
23
|
|
Overall Study
LY3502970 - 3 mg
|
24
|
24
|
22
|
|
Overall Study
COMPLETED
|
24
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
LY3502970 Cohort 1
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
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
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY3502970 in Healthy Overweight and Obese Participants
Baseline characteristics by cohort
| Measure |
LY3502970 Cohort 1
n=24 Participants
Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.
|
LY3502970 Cohort 2
n=24 Participants
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
n=24 Participants
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.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 14.1 • n=20 Participants
|
42.3 years
STANDARD_DEVIATION 13.4 • n=32 Participants
|
46.1 years
STANDARD_DEVIATION 14.8 • n=64 Participants
|
43.4 years
STANDARD_DEVIATION 14.1 • n=50 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
11 Participants
n=32 Participants
|
10 Participants
n=64 Participants
|
26 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=20 Participants
|
13 Participants
n=32 Participants
|
14 Participants
n=64 Participants
|
46 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=20 Participants
|
10 Participants
n=32 Participants
|
9 Participants
n=64 Participants
|
33 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=20 Participants
|
14 Participants
n=32 Participants
|
15 Participants
n=64 Participants
|
39 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
11 Participants
n=32 Participants
|
4 Participants
n=64 Participants
|
18 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=20 Participants
|
11 Participants
n=32 Participants
|
17 Participants
n=64 Participants
|
48 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
2 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
2 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=20 Participants
|
24 Participants
n=32 Participants
|
24 Participants
n=64 Participants
|
72 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 42Population: All enrolled participants who received at least one dose of study drug.
A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in one of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, 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 participant or may require intervention to prevent one of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.
Outcome measures
| Measure |
LY3502970 Cohort 2
n=24 Participants
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
n=24 Participants
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.
|
LY3502970 Cohort 1
n=24 Participants
Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.
|
|---|---|---|---|
|
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
21 participants
|
16 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)Population: All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 1.
PK: AUC\[0-tlast\] of LY3502970
Outcome measures
| Measure |
LY3502970 Cohort 2
n=20 Participants
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
n=20 Participants
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.
|
LY3502970 Cohort 1
n=20 Participants
Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1
|
66.1 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 25
|
66.9 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 30
|
117 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 39
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)Population: All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 1.
PK: Cmax of LY3502970
Outcome measures
| Measure |
LY3502970 Cohort 2
n=20 Participants
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
n=20 Participants
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.
|
LY3502970 Cohort 1
n=20 Participants
Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.
|
|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1
|
4.97 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
5.00 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
8.40 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
SECONDARY outcome
Timeframe: Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)Population: All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 1.
PK: Tmax of LY3502970
Outcome measures
| Measure |
LY3502970 Cohort 2
n=20 Participants
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
n=20 Participants
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.
|
LY3502970 Cohort 1
n=20 Participants
Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.
|
|---|---|---|---|
|
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 on Day 1
|
6.00 hours (h)
Interval 4.0 to 8.0
|
6.00 hours (h)
Interval 4.0 to 8.0
|
7.03 hours (h)
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)Population: All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 28.
PK: AUC\[0-tlast\] of LY3502970
Outcome measures
| Measure |
LY3502970 Cohort 2
n=23 Participants
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
n=22 Participants
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.
|
LY3502970 Cohort 1
n=24 Participants
Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.
|
|---|---|---|---|
|
PK: AUC[0-tlast] of LY3502970 on Day 28
|
277 ng*h/mL
Geometric Coefficient of Variation 34
|
314 ng*h/mL
Geometric Coefficient of Variation 26
|
275 ng*h/mL
Geometric Coefficient of Variation 40
|
SECONDARY outcome
Timeframe: Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)Population: All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 28.
PK: Cmax of LY3502970
Outcome measures
| Measure |
LY3502970 Cohort 2
n=23 Participants
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
n=22 Participants
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.
|
LY3502970 Cohort 1
n=24 Participants
Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.
|
|---|---|---|---|
|
PK: Cmax of LY3502970 on Day 28
|
18.4 ng/mL
Geometric Coefficient of Variation 41
|
21.2 ng/mL
Geometric Coefficient of Variation 35
|
18.4 ng/mL
Geometric Coefficient of Variation 43
|
SECONDARY outcome
Timeframe: Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)Population: All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 28.
PK: Tmax of LY3502970
Outcome measures
| Measure |
LY3502970 Cohort 2
n=23 Participants
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
n=22 Participants
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.
|
LY3502970 Cohort 1
n=24 Participants
Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.
|
|---|---|---|---|
|
PK: Tmax of LY3502970 on Day 28
|
6.00 h
Interval 4.0 to 12.0
|
6.00 h
Interval 4.0 to 8.0
|
6.00 h
Interval 4.0 to 12.0
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: All participants who received at least one dose of LY3502970.
PD: Change From Baseline in Body Weight
Outcome measures
| Measure |
LY3502970 Cohort 2
n=24 Participants
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
n=24 Participants
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.
|
LY3502970 Cohort 1
n=24 Participants
Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.
|
|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Body Weight
|
-5.5 kilograms (kg)
Standard Deviation 3.5
|
-3.6 kilograms (kg)
Standard Deviation 1.9
|
-4.2 kilograms (kg)
Standard Deviation 2.5
|
Adverse Events
LY3502970 Cohort 1
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
LY3502970 Cohort 2
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
LY3502970 Cohort 3
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY3502970 Cohort 1
n=24 participants at risk
Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD.
|
LY3502970 Cohort 2
n=24 participants at risk
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
n=24 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.2%
1/24 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
4.2%
1/24 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
8.3%
2/24 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
8.3%
2/24 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
0.00%
0/24 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
9/24 • Number of events 9 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
33.3%
8/24 • Number of events 8 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
25.0%
6/24 • Number of events 6 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
4/24 • Number of events 4 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
20.8%
5/24 • Number of events 5 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
8.3%
2/24 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
4/24 • Number of events 4 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
41.7%
10/24 • Number of events 11 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
25.0%
6/24 • Number of events 7 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Gastrointestinal disorders
Eructation
|
8.3%
2/24 • Number of events 3 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
0.00%
0/24 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
12.5%
3/24 • Number of events 4 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
3/24 • Number of events 5 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
0.00%
0/24 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
4.2%
1/24 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
4/24 • Number of events 6 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
25.0%
6/24 • Number of events 6 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
8.3%
2/24 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
16.7%
4/24 • Number of events 6 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
4.2%
1/24 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Investigations
Weight decreased
|
25.0%
6/24 • Number of events 6 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
29.2%
7/24 • Number of events 7 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
12.5%
3/24 • Number of events 3 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
2/24 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
4.2%
1/24 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
4.2%
1/24 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
|
Nervous system disorders
Headache
|
33.3%
8/24 • Number of events 14 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
20.8%
5/24 • Number of events 6 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
16.7%
4/24 • Number of events 4 • Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60