Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Healthy Participants (NCT NCT03375463)
NCT ID: NCT03375463
Last Updated: 2024-02-05
Results Overview
Pharmacokinetics (PK) Part A: Area under the concentration versus time curve \[AUC (0-∞)\] of tirzepatide.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose
Results posted on
2024-02-05
Participant Flow
4-part study, Part A (2-period, 2-treatment, crossover study with at least 35 days of washout period), Part B (fixed, single-arm treatment study), Part C (placebo-controlled, 4-week dose escalation study) and Part D (a fixed, single-arm treatment study).
Participant milestones
| Measure |
Sequence 1-Part A
Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation in Period 1 and 5 mg of tirzepatide SC lyophilized formulation in Period 2.
|
Sequence 2-Part A
Participants received 5 mg of tirzepatide SC lyophilized formulation in Period 1 and 5 mg of tirzepatide SC solution formulation in Period 2.
|
0.5 mg Tirzepatide IV-Part B
Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide solution formulation.
|
Placebo SC-Part C
Participants received SC injection of placebo.
|
5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C
Participants received tirzepatide subcutaneous solution formulation at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4).
|
0.5 mg Tirzepatide Bolus IV-Part D
Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
10
|
10
|
8
|
4
|
12
|
8
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
10
|
10
|
8
|
4
|
12
|
8
|
|
Period 1
COMPLETED
|
10
|
10
|
7
|
4
|
11
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Period 2
STARTED
|
10
|
10
|
0
|
0
|
0
|
0
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
10
|
10
|
0
|
0
|
0
|
0
|
|
Period 2
COMPLETED
|
9
|
9
|
0
|
0
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1-Part A
Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation in Period 1 and 5 mg of tirzepatide SC lyophilized formulation in Period 2.
|
Sequence 2-Part A
Participants received 5 mg of tirzepatide SC lyophilized formulation in Period 1 and 5 mg of tirzepatide SC solution formulation in Period 2.
|
0.5 mg Tirzepatide IV-Part B
Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide solution formulation.
|
Placebo SC-Part C
Participants received SC injection of placebo.
|
5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C
Participants received tirzepatide subcutaneous solution formulation at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4).
|
0.5 mg Tirzepatide Bolus IV-Part D
Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation.
|
|---|---|---|---|---|---|---|
|
Period 1
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Tirzepatide (LY3298176) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Sequence 1-Part A
n=10 Participants
Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation in Period 1 and 5 mg of tirzepatide SC lyophilized formulation in Period 2.
|
Sequence 2-Part A
n=10 Participants
Participants received 5 mg of tirzepatide SC lyophilized formulation in Period 1 and 5 mg of tirzepatide SC solution formulation in Period 2.
|
0.5 mg Tirzepatide IV-Part B
n=8 Participants
Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide solution formulation.
|
Placebo SC-Part C
n=4 Participants
Participants received SC injection of placebo.
|
5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C
n=12 Participants
Participants received tirzepatide subcutaneous solution formulation at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4).
|
0.5 mg Tirzepatide Bolus IV-Part D
n=8 Participants
Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
11 Participants
n=390 Participants
|
8 Participants
n=16 Participants
|
51 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
7 Participants
n=390 Participants
|
4 Participants
n=16 Participants
|
15 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
5 Participants
n=390 Participants
|
4 Participants
n=16 Participants
|
37 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
2 Participants
n=16 Participants
|
9 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
11 Participants
n=390 Participants
|
6 Participants
n=16 Participants
|
43 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
8 Participants
n=390 Participants
|
4 Participants
n=16 Participants
|
29 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
4 Participants
n=390 Participants
|
3 Participants
n=16 Participants
|
20 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
8 participants
n=206 Participants
|
4 participants
n=157 Participants
|
12 participants
n=390 Participants
|
8 participants
n=16 Participants
|
52 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdosePopulation: All randomized participants from Part A group, who received at least one dose of study drug and had evaluable PK data
Pharmacokinetics (PK) Part A: Area under the concentration versus time curve \[AUC (0-∞)\] of tirzepatide.
Outcome measures
| Measure |
5 mg Tirzepatide SC (Lyophilized)-Part A
n=19 Participants
Participants received 5 mg of tirzepatide SC lyophilized formulation.
|
5 mg Tirzepatide SC (Solution)-Part A
n=20 Participants
Participants received 5 mg of tirzepatide SC solution formulation.
|
10 mg Tirzepatide SC-Part C
Participants received 10 mg of tirzepatide subcutaneous solution formulation on day 22 (week 4).
|
|---|---|---|---|
|
Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
|
113000 nanograms*hours per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 19
|
109000 nanograms*hours per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 17
|
—
|
PRIMARY outcome
Timeframe: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480 and 816-864 hours postdosePopulation: All randomized participants from Part A group, who received at least one dose of study drug and had evaluable PK data.
PK Part A: Maximum observed plasma drug concentration (Cmax) of tirzepatide.
Outcome measures
| Measure |
5 mg Tirzepatide SC (Lyophilized)-Part A
n=20 Participants
Participants received 5 mg of tirzepatide SC lyophilized formulation.
|
5 mg Tirzepatide SC (Solution)-Part A
n=20 Participants
Participants received 5 mg of tirzepatide SC solution formulation.
|
10 mg Tirzepatide SC-Part C
Participants received 10 mg of tirzepatide subcutaneous solution formulation on day 22 (week 4).
|
|---|---|---|---|
|
PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
|
524 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
575 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
—
|
PRIMARY outcome
Timeframe: Part B: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816h-864h and >=70 days post dosePopulation: All randomized participants from Part B group, who received at least one dose of study drug and had evaluable PK data.
PK Part B: Area under the concentration versus time curve \[AUC (0-∞)\] of tirzepatide.
Outcome measures
| Measure |
5 mg Tirzepatide SC (Lyophilized)-Part A
n=8 Participants
Participants received 5 mg of tirzepatide SC lyophilized formulation.
|
5 mg Tirzepatide SC (Solution)-Part A
Participants received 5 mg of tirzepatide SC solution formulation.
|
10 mg Tirzepatide SC-Part C
Participants received 10 mg of tirzepatide subcutaneous solution formulation on day 22 (week 4).
|
|---|---|---|---|
|
PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
|
6680 ng*hr/mL
Geometric Coefficient of Variation 26
|
—
|
—
|
SECONDARY outcome
Timeframe: Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdosePopulation: All randomized participants from Part C group, who received at least one dose of study drug and had evaluable PK data. As per planned analysis, for 10 mg Tirzepatide SC-Part C arm, no PK samples were collected at 168 hour post dose (after the fourth dose. i.e. following dose at Week 4). Hence, no data was collected to calculate AUC (0-τ) for 10 mg Tirzepatide SC-Part C arm.
PK Part C: Area under the concentration versus time curve during one dosing interval (168 hours) \[AUC (0-τ)\] of tirzepatide.
Outcome measures
| Measure |
5 mg Tirzepatide SC (Lyophilized)-Part A
n=12 Participants
Participants received 5 mg of tirzepatide SC lyophilized formulation.
|
5 mg Tirzepatide SC (Solution)-Part A
n=12 Participants
Participants received 5 mg of tirzepatide SC solution formulation.
|
10 mg Tirzepatide SC-Part C
Participants received 10 mg of tirzepatide subcutaneous solution formulation on day 22 (week 4).
|
|---|---|---|---|
|
PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-τ)] of Tirzepatide
|
68900 ng*hr/mL
Geometric Coefficient of Variation 19
|
149000 ng*hr/mL
Geometric Coefficient of Variation 26
|
—
|
SECONDARY outcome
Timeframe: Part C: Predose, 8 hours (h) (day (D)1), 24h (D2), 48h (D3),72h (D4), predose (D8), predose (D15), 8h (D15), 24h (D16), 48h (D17), 72h (D18), predose (D22), 8h (D22), 24h (D23), 48h (D24), 72h (D25), D57 and >= D96 postdosePopulation: All randomized participants participants from Part C group, who received at least one dose of study drug and had evaluable PK data.
PK Part C: Maximum observed plasma drug concentration (Cmax) of tirzepatide.
Outcome measures
| Measure |
5 mg Tirzepatide SC (Lyophilized)-Part A
n=12 Participants
Participants received 5 mg of tirzepatide SC lyophilized formulation.
|
5 mg Tirzepatide SC (Solution)-Part A
n=12 Participants
Participants received 5 mg of tirzepatide SC solution formulation.
|
10 mg Tirzepatide SC-Part C
n=11 Participants
Participants received 10 mg of tirzepatide subcutaneous solution formulation on day 22 (week 4).
|
|---|---|---|---|
|
PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide
|
663 ng/mL
Geometric Coefficient of Variation 23
|
1270 ng/mL
Geometric Coefficient of Variation 24
|
1900 ng/mL
Geometric Coefficient of Variation 24
|
SECONDARY outcome
Timeframe: Part D: Predose, 0.08 hours (h), 0.16h, 0.5h, 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 816-864h and >= 70 days postdosePopulation: All randomized participants from Part D group, who received at least one dose of study drug and had evaluable PK data.
PK Part D: Area under the concentration versus time curve \[AUC (0-∞)\] of tirzepatide.
Outcome measures
| Measure |
5 mg Tirzepatide SC (Lyophilized)-Part A
n=8 Participants
Participants received 5 mg of tirzepatide SC lyophilized formulation.
|
5 mg Tirzepatide SC (Solution)-Part A
Participants received 5 mg of tirzepatide SC solution formulation.
|
10 mg Tirzepatide SC-Part C
Participants received 10 mg of tirzepatide subcutaneous solution formulation on day 22 (week 4).
|
|---|---|---|---|
|
PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
|
14000 ng*hr/mL
Geometric Coefficient of Variation 16
|
—
|
—
|
Adverse Events
5 mg Tirzepatide SC (Lyophilized)-Part A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
5 mg Tirzepatide SC (Solution)-Part A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.5 mg Tirzepatide IV-Part B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo SC-Part C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
5 mg Tirzepatide SC, First-Part C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
5 mg Tirzepatide SC, Second Dose-Part C
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
7.5 mg LY3298176 SC-Part C
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
10 mg Tirzepatide SC-Part C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.5 mg Tirzepatide Bolus IV-Part D
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
5 mg Tirzepatide SC (Lyophilized)-Part A
n=20 participants at risk
Participants received 5 mg of tirzepatide SC lyophilized formulation.
|
5 mg Tirzepatide SC (Solution)-Part A
n=20 participants at risk
Participants received 5 mg of tirzepatide SC solution formulation.
|
0.5 mg Tirzepatide IV-Part B
n=8 participants at risk
Participants received IV infusion of a single 0.5 mg dose of tirzepatide solution formulation.
|
Placebo SC-Part C
n=4 participants at risk
Participants received SC injection of placebo.
|
5 mg Tirzepatide SC, First-Part C
n=12 participants at risk
Participants received 5 mg of tirzepatide subcutaneous solution formulation on day 1 (week 1).
|
5 mg Tirzepatide SC, Second Dose-Part C
n=12 participants at risk
Participants received 5 mg of tirzepatide subcutaneous solution formulation on day 8 (Week 2).
|
7.5 mg LY3298176 SC-Part C
n=12 participants at risk
Participants received 7.5 mg of tirzepatide subcutaneous solution formulation on day 15 (week 3).
|
10 mg Tirzepatide SC-Part C
n=11 participants at risk
Participants received 10 mg of tirzepatide subcutaneous solution formulation on day 22 (week 4).
|
0.5 mg Tirzepatide Bolus IV-Part D
n=8 participants at risk
Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
9.1%
1/11 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Number of events 2 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
15.0%
3/20 • Number of events 4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
16.7%
2/12 • Number of events 3 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
9.1%
1/11 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
3/20 • Number of events 3 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
5.0%
1/20 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 2 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
12.5%
1/8 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Number of events 4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
10.0%
2/20 • Number of events 2 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
16.7%
2/12 • Number of events 2 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
25.0%
3/12 • Number of events 4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
9.1%
1/11 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
12.5%
1/8 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
12.5%
1/8 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 2 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
5.0%
1/20 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
General disorders
Injection site reaction
|
25.0%
5/20 • Number of events 6 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
10.0%
2/20 • Number of events 2 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
16.7%
2/12 • Number of events 2 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
27.3%
3/11 • Number of events 3 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
12.5%
1/8 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
16.7%
2/12 • Number of events 2 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 2 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
25.0%
1/4 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
27.3%
3/11 • Number of events 4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
9.1%
1/11 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
8.3%
1/12 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/20 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/8 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/4 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/12 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
0.00%
0/11 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
12.5%
1/8 • Number of events 1 • Up To 92 Days
All randomized participants who received at least one dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60