Trial Outcomes & Findings for Pharmacokinetics of Leptin Administration During Fasting (NCT NCT00140205)
NCT ID: NCT00140205
Last Updated: 2018-11-02
Results Overview
72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
3 DAY
Results posted on
2018-11-02
Participant Flow
Participant milestones
| Measure |
5 LEAN MEN Fasting State (72 Hrs) on 0.3mg/kg Leptin
5 lean men were fasted for 72 hrs and during that period recieved 0.3mg/kg leptin
|
5 OBESE MEN 72 HR FASTING on 0.3mg/kg Leptin
5 obese men were fasted for 72 hrs and during that period received 0.3mg/kg leptin
|
5 LEAN WOMEN 72 HR FATSING on 0.3mg/kg Leptin
5 lean women were fasted for 72 hrs and during that period received 0.3mg/kg leptin
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Leptin Administration During Fasting
Baseline characteristics by cohort
| Measure |
LEAN MEN 24h Fed or 72h Fasting in Different Leptin Doses
n=5 Participants
5 lean men were fasted for 72 hrs and during that period received 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit)
|
OBESE MEN 24h Fed or 72h Fasting in Different Leptin Doses
n=5 Participants
5 obese men were fasted for 72 hrs and during that period recieved 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit)
|
OBESE WOMEN 24h Fed or 72h Fasting in Different Leptin Doses
n=5 Participants
5 lean women were fasted for 72 hrs and during that period received 0.01 mg/kg leptin (First visit), 0,1 mg/kg (Second visit), 0.3 mg/kg (Third visit)
|
Total
n=15 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=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
22 YEARS
STANDARD_DEVIATION .09 • n=99 Participants
|
23 YEARS
STANDARD_DEVIATION .08 • n=107 Participants
|
22 YEARS
STANDARD_DEVIATION .05 • n=206 Participants
|
23 YEARS
STANDARD_DEVIATION .07 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
BMI
BMI>30kg/m2
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
0 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
BMI
BMI<25kg/m2
|
5 participants
n=99 Participants
|
0 participants
n=107 Participants
|
5 participants
n=206 Participants
|
10 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3 DAY72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
TIME(T1/2) DAY 3
|
1.93 HR
Standard Deviation 0.28
|
2.75 HR
Standard Deviation 1.49
|
2.99 HR
Standard Deviation 1.01
|
|
Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
TMAX DAY 3
|
2.00 HR
Standard Deviation 0.71
|
3.00 HR
Standard Deviation 0.71
|
2.80 HR
Standard Deviation 1.30
|
PRIMARY outcome
Timeframe: 3 DAY72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
c(MAX)
|
2.60 NG/ML
Standard Deviation 0.59
|
4.21 NG/ML
Standard Deviation 1.17
|
4.62 NG/ML
Standard Deviation 1.60
|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
L0 (ENDOGENOUS LEPTIN LEVEL)
|
1.42 NG/ML
Standard Deviation 0.72
|
3.32 NG/ML
Standard Deviation 1.21
|
3.53 NG/ML
Standard Deviation 1.26
|
PRIMARY outcome
Timeframe: 3 DAY72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg
|
12.27 NG*H/ML
Standard Deviation 2.95
|
35.43 NG*H/ML
Standard Deviation 13.81
|
47.81 NG*H/ML
Standard Deviation 23.90
|
PRIMARY outcome
Timeframe: 3 DAY72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
TIME(T1/2) DAY 3
|
1.82 HR
Standard Deviation 0.58
|
3.10 HR
Standard Deviation 1.20
|
1.73 HR
Standard Deviation 0.57
|
|
Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
TMAX DAY 3
|
3.20 HR
Standard Deviation 1.10
|
4.00 HR
Standard Deviation 1.58
|
3.00 HR
Standard Deviation 1.00
|
PRIMARY outcome
Timeframe: 3 DAY72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
c(MAX)
|
33.88 NG/ML
Standard Deviation 9.38
|
78.43 NG/ML
Standard Deviation 14.71
|
106.4 NG/ML
Standard Deviation 36.7
|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
L0 (ENDOGENOUS LEPTIN LEVEL)
|
1.69 NG/ML
Standard Deviation 0.89
|
5.92 NG/ML
Standard Deviation 1.33
|
5.36 NG/ML
Standard Deviation 1.89
|
PRIMARY outcome
Timeframe: 3 DAY72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg
|
206.9 NG*H/ML
Standard Deviation 56.9
|
778.2 NG*H/ML
Standard Deviation 121.5
|
676.5 NG*H/ML
Standard Deviation 267.4
|
PRIMARY outcome
Timeframe: 3 DAY72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
TIME(T1/2) DAY 3
|
1.98 HR
Standard Deviation 0.28
|
2.40 HR
Standard Deviation 0.54
|
1.92 HR
Standard Deviation 0.45
|
|
Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
TMAX DAY 3
|
3.80 HR
Standard Deviation 1.30
|
3.40 HR
Standard Deviation 1.67
|
3.80 HR
Standard Deviation 1.48
|
PRIMARY outcome
Timeframe: 3 DAY72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
c(MAX)
|
88.39 NG/ML
Standard Deviation 32.13
|
301.6 NG/ML
Standard Deviation 86.8
|
399.6 NG/ML
Standard Deviation 76.8
|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
L0 (ENDOGENOUS LEPTIN LEVEL)
|
1.62 NG/ML
Standard Deviation 0.64
|
13.72 NG/ML
Standard Deviation 2.97
|
6.95 NG/ML
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: 3 DAY72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg
|
747.3 NG*H/ML
Standard Deviation 300.8
|
2717 NG*H/ML
Standard Deviation 647.1
|
2738 NG*H/ML
Standard Deviation 624
|
PRIMARY outcome
Timeframe: 1 DAY24-hour fed Leptin dose 0.3 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg
TIME(T1/2)
|
2.94 HR
Standard Deviation 0.95
|
3.69 HR
Standard Deviation 1.13
|
2.91 HR
Standard Deviation 0.90
|
|
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg
TMAX
|
3.60 HR
Standard Deviation 0.89
|
3.40 HR
Standard Deviation 1.67
|
2.80 HR
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: 1 DAY24-hour fed Leptin dose 0.3 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg
c(MAX)
|
168.7 NG/ML
Standard Deviation 61.7
|
254.3 NG/ML
Standard Deviation 36.7
|
440.7 NG/ML
Standard Deviation 85.2
|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg
L0 (ENDOGENOUS LEPTIN LEVEL)
|
2.97 NG/ML
Standard Deviation 0.68
|
16.24 NG/ML
Standard Deviation 5.00
|
12.60 NG/ML
Standard Deviation 7.78
|
PRIMARY outcome
Timeframe: 1 DAY24-hour fed Leptin dose 0.3 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg
|
1243 NG*H/ML
Standard Deviation 304.2
|
2948 NG*H/ML
Standard Deviation 521.9
|
3300 NG*H/ML
Standard Deviation 871
|
PRIMARY outcome
Timeframe: 1 DAY24-hour fed Leptin dose 0.01 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg
TIME(T1/2)
|
2.84 HR
Standard Deviation 0.98
|
4.71 HR
Standard Deviation 2.16
|
3.08 HR
Standard Deviation 1.24
|
|
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg
TMAX
|
3.00 HR
Standard Deviation 1.00
|
6.20 HR
Standard Deviation 3.35
|
2.80 HR
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: 1 DAY24-hour fed Leptin dose 0.01 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg
c(MAX)
|
5.97 NG/ML
Standard Deviation 1.65
|
7.91 NG/ML
Standard Deviation 2.37
|
14.51 NG/ML
Standard Deviation 2.96
|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg
L0 (ENDOGENOUS LEPTIN LEVEL)
|
2.32 NG/ML
Standard Deviation 0.48
|
12.67 NG/ML
Standard Deviation 6.15
|
15.54 NG/ML
Standard Deviation 8.90
|
PRIMARY outcome
Timeframe: 1 DAY24-hour fed Leptin dose 0.01 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg
|
33.18 NG*H/ML
Standard Deviation 8.68
|
113.9 NG*H/ML
Standard Deviation 56.6
|
110.5 NG*H/ML
Standard Deviation 45.0
|
PRIMARY outcome
Timeframe: 1 DAY24-hour fed Leptin dose 0.1 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg
TIME(T1/2)
|
2.89 HR
Standard Deviation 0.24
|
4.72 HR
Standard Deviation 1.51
|
2.08 HR
Standard Deviation 1.01
|
|
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg
TMAX
|
3.00 HR
Standard Deviation 1.58
|
4.60 HR
Standard Deviation 0.89
|
3.20 HR
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: 1 DAY24-hour fed Leptin dose 0.1 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg
c(MAX)
|
72.56 NG/ML
Standard Deviation 12.19
|
77.26 NG/ML
Standard Deviation 10.10
|
107.4 NG/ML
Standard Deviation 19.4
|
|
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg
L0 (ENDOGENOUS LEPTIN LEVEL)
|
2.11 NG/ML
Standard Deviation 0.50
|
15.49 NG/ML
Standard Deviation 8.64
|
14.36 NG/ML
Standard Deviation 11.12
|
PRIMARY outcome
Timeframe: 1 DAY24-hour fed Leptin dose 0.1 mg/kg
Outcome measures
| Measure |
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kg
n=5 Participants
|
|---|---|---|---|
|
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg
|
507.4 NG*H/ML
Standard Deviation 44.1
|
1051 NG*H/ML
Standard Deviation 202.9
|
620.2 NG*H/ML
Standard Deviation 157.1
|
SECONDARY outcome
Timeframe: 1 DAY or DAY 3Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 DAY or DAY 3Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: day 3 of fasting and day 1 of fed stateData were collected neither in Fed nor in Fasting state for the different doses of leptin
Outcome measures
Outcome data not reported
Adverse Events
Fasting State (72 Hrs)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place