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Pharmacokinetics of Leptin Administration During Fasting

Pharmacokinetics of Leptin Administration During Fasting

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00140205
Enrollment
15
Registered
2005-09-01
Start date
2001-02-28
Completion date
2016-12-31
Last updated
2018-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Energy Deficiency Due to Short-term Fasting

Keywords

leptin, fasting, pharmacokinetics

Brief summary

The purpose of this study will be to determine the correct dose of leptin, a natural hormone secreted by the fat cells, to give to people when they are fasting and also to determine whether giving leptin to a person when he or she is fasting will reverse the changes in hormone levels that occur with fasting.

Detailed description

Leptin is a newly-identified hormone secreted by fat cells under normal conditions that acts in the brain to decrease appetite and increase long term energy usage. Leptin levels usually go down when people are not eating for extended periods of time. Changes in metabolism and certain hormone levels also occur with fasting. By studying the pharmacokinetics of leptin administration, we can evaluate the changes of leptin levels in response to giving different doses of leptin as well as acute changes of other hormones in response to leptin levels. Investigations such as this one have important implications for the future therapeutic use of leptin, including determining the appropriate dose of leptin to use in future studies involving leptin administration. Comparison: subjects receiving leptin at 3 different doses in the fed state compared to the fasting state

Interventions

DRUGr-metHuLeptin

r-metreleptin was given in 3 different dose in fed and fasting states

Sponsors

Amgen
CollaboratorINDUSTRY
Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy men with body mass indices (BMI) \<25 kg/m2) * overweight otherwise healthy men with BMI \> 27 kg/m2 * healthy lean women with BMI\<25 kg/m2 * overweight otherwise healthy women with BMI \> 27 kg/m2

Exclusion criteria

* history of any illness that may affect the concentrations of the hormones that will be studied (such as anemia, infectious diseases, renal or hepatic failure, diabetes mellitus, cancer, lymphoma, hypogonadism, malabsorption or malnourishment, hypo or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders) * on medications known to affect the hormones to be measured in this study (such as glucocorticoids, anti-seizure medications or thyroid hormones) * known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to E. Coli derived proteins * women who are breast feeding, pregnant, or wanting to become pregnant during the next 6 months

Design outcomes

Primary

MeasureTime frameDescription
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg1 DAY24-hour fed Leptin dose 0.1 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg1 DAY24-hour fed Leptin dose 0.01 mg/kg
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg1 DAY24-hour fed Leptin dose 0.01 mg/kg
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg1 DAY24-hour fed Leptin dose 0.1 mg/kg
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg1 DAY24-hour fed Leptin dose 0.1 mg/kg
Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg3 DAY72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg3 DAY72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg3 DAY72-hour fasting Day 3 Leptin dose 0.01 mg/kg
Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg3 DAY72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg3 DAY72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg3 DAY72-hour fasting Day 3 Leptin dose 0.1 mg/kg
Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg3 DAY72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg3 DAY72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg3 DAY72-hour fasting Day 3 Leptin dose 0.3 mg/kg
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg1 DAY24-hour fed Leptin dose 0.3 mg/kg
Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg1 DAY24-hour fed Leptin dose 0.3 mg/kg
Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg1 DAY24-hour fed Leptin dose 0.3 mg/kg
Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg1 DAY24-hour fed Leptin dose 0.01 mg/kg

Secondary

MeasureTime frameDescription
Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)1 DAY or DAY 3Data were collected neither in Fed nor in Fasting state for the different doses of leptin
Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)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
Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)1 DAY or DAY 3Data were collected neither in Fed nor in Fasting state for the different doses of leptin

Countries

United States

Participant flow

Participants by arm

ArmCount
LEAN MEN 24h Fed or 72h Fasting in Different Leptin Doses
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)
5
OBESE MEN 24h Fed or 72h Fasting in Different Leptin Doses
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)
5
OBESE WOMEN 24h Fed or 72h Fasting in Different Leptin Doses
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)
5
Total15

Baseline characteristics

CharacteristicOBESE MEN 24h Fed or 72h Fasting in Different Leptin DosesLEAN MEN 24h Fed or 72h Fasting in Different Leptin DosesOBESE WOMEN 24h Fed or 72h Fasting in Different Leptin DosesTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
5 Participants5 Participants5 Participants15 Participants
Age, Continuous23 YEARS
STANDARD_DEVIATION 0.08
22 YEARS
STANDARD_DEVIATION 0.09
22 YEARS
STANDARD_DEVIATION 0.05
23 YEARS
STANDARD_DEVIATION 0.07
BMI
BMI<25kg/m2
0 participants5 participants5 participants10 participants
BMI
BMI>30kg/m2
5 participants0 participants0 participants5 participants
Region of Enrollment
United States
5 Participants5 Participants5 Participants15 Participants
Sex: Female, Male
Female
0 Participants0 Participants5 Participants5 Participants
Sex: Female, Male
Male
5 Participants5 Participants0 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 15
other
Total, other adverse events
0 / 15
serious
Total, serious adverse events
0 / 15

Outcome results

Primary

Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

72-hour fasting Day 3 Leptin dose 0.01 mg/kg

Time frame: 3 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgTIME(T1/2) DAY 31.93 HRStandard Deviation 0.28
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgTMAX DAY 32.00 HRStandard Deviation 0.71
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgTIME(T1/2) DAY 32.75 HRStandard Deviation 1.49
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgTMAX DAY 33.00 HRStandard Deviation 0.71
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgTIME(T1/2) DAY 32.99 HRStandard Deviation 1.01
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgTMAX DAY 32.80 HRStandard Deviation 1.3
Primary

Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg

72-hour fasting Day 3 Leptin dose 0.1 mg/kg

Time frame: 3 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgTIME(T1/2) DAY 31.82 HRStandard Deviation 0.58
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgTMAX DAY 33.20 HRStandard Deviation 1.1
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgTIME(T1/2) DAY 33.10 HRStandard Deviation 1.2
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgTMAX DAY 34.00 HRStandard Deviation 1.58
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgTIME(T1/2) DAY 31.73 HRStandard Deviation 0.57
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgTMAX DAY 33.00 HRStandard Deviation 1
Primary

Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg

72-hour fasting Day 3 Leptin dose 0.3 mg/kg

Time frame: 3 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgTIME(T1/2) DAY 31.98 HRStandard Deviation 0.28
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgTMAX DAY 33.80 HRStandard Deviation 1.3
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgTIME(T1/2) DAY 32.40 HRStandard Deviation 0.54
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgTMAX DAY 33.40 HRStandard Deviation 1.67
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgTIME(T1/2) DAY 31.92 HRStandard Deviation 0.45
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgTMAX DAY 33.80 HRStandard Deviation 1.48
Primary

Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg

24-hour fed Leptin dose 0.01 mg/kg

Time frame: 1 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kgTIME(T1/2)2.84 HRStandard Deviation 0.98
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kgTMAX3.00 HRStandard Deviation 1
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kgTIME(T1/2)4.71 HRStandard Deviation 2.16
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kgTMAX6.20 HRStandard Deviation 3.35
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kgTIME(T1/2)3.08 HRStandard Deviation 1.24
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kgTMAX2.80 HRStandard Deviation 0.84
Primary

Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg

24-hour fed Leptin dose 0.1 mg/kg

Time frame: 1 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kgTIME(T1/2)2.89 HRStandard Deviation 0.24
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kgTMAX3.00 HRStandard Deviation 1.58
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kgTIME(T1/2)4.72 HRStandard Deviation 1.51
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kgTMAX4.60 HRStandard Deviation 0.89
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kgTIME(T1/2)2.08 HRStandard Deviation 1.01
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kgTMAX3.20 HRStandard Deviation 0.84
Primary

Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg

24-hour fed Leptin dose 0.3 mg/kg

Time frame: 1 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kgTIME(T1/2)2.94 HRStandard Deviation 0.95
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kgTMAX3.60 HRStandard Deviation 0.89
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kgTIME(T1/2)3.69 HRStandard Deviation 1.13
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kgTMAX3.40 HRStandard Deviation 1.67
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kgTIME(T1/2)2.91 HRStandard Deviation 0.9
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kgTMAX2.80 HRStandard Deviation 0.84
Primary

Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg

24-hour fed Leptin dose 0.01 mg/kg

Time frame: 1 DAY

ArmMeasureValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg33.18 NG*H/MLStandard Deviation 8.68
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg113.9 NG*H/MLStandard Deviation 56.6
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg110.5 NG*H/MLStandard Deviation 45
Primary

Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg

24-hour fed Leptin dose 0.1 mg/kg

Time frame: 1 DAY

ArmMeasureValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg507.4 NG*H/MLStandard Deviation 44.1
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg1051 NG*H/MLStandard Deviation 202.9
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg620.2 NG*H/MLStandard Deviation 157.1
Primary

Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg

24-hour fed Leptin dose 0.3 mg/kg

Time frame: 1 DAY

ArmMeasureValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg1243 NG*H/MLStandard Deviation 304.2
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg2948 NG*H/MLStandard Deviation 521.9
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg3300 NG*H/MLStandard Deviation 871
Primary

Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

72-hour fasting Day 3 Leptin dose 0.01 mg/kg

Time frame: 3 DAY

ArmMeasureValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg12.27 NG*H/MLStandard Deviation 2.95
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg35.43 NG*H/MLStandard Deviation 13.81
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg47.81 NG*H/MLStandard Deviation 23.9
Primary

Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg

72-hour fasting Day 3 Leptin dose 0.1 mg/kg

Time frame: 3 DAY

ArmMeasureValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg206.9 NG*H/MLStandard Deviation 56.9
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg778.2 NG*H/MLStandard Deviation 121.5
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg676.5 NG*H/MLStandard Deviation 267.4
Primary

Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg

72-hour fasting Day 3 Leptin dose 0.3 mg/kg

Time frame: 3 DAY

ArmMeasureValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg747.3 NG*H/MLStandard Deviation 300.8
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg2717 NG*H/MLStandard Deviation 647.1
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg2738 NG*H/MLStandard Deviation 624
Primary

Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg

24-hour fed Leptin dose 0.01 mg/kg

Time frame: 1 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kgc(MAX)5.97 NG/MLStandard Deviation 1.65
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)2.32 NG/MLStandard Deviation 0.48
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kgc(MAX)7.91 NG/MLStandard Deviation 2.37
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)12.67 NG/MLStandard Deviation 6.15
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kgc(MAX)14.51 NG/MLStandard Deviation 2.96
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)15.54 NG/MLStandard Deviation 8.9
Primary

Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg

24-hour fed Leptin dose 0.1 mg/kg

Time frame: 1 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kgc(MAX)72.56 NG/MLStandard Deviation 12.19
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)2.11 NG/MLStandard Deviation 0.5
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kgc(MAX)77.26 NG/MLStandard Deviation 10.1
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)15.49 NG/MLStandard Deviation 8.64
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kgc(MAX)107.4 NG/MLStandard Deviation 19.4
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)14.36 NG/MLStandard Deviation 11.12
Primary

Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg

24-hour fed Leptin dose 0.3 mg/kg

Time frame: 1 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kgc(MAX)168.7 NG/MLStandard Deviation 61.7
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)2.97 NG/MLStandard Deviation 0.68
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kgc(MAX)254.3 NG/MLStandard Deviation 36.7
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)16.24 NG/MLStandard Deviation 5
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kgc(MAX)440.7 NG/MLStandard Deviation 85.2
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)12.60 NG/MLStandard Deviation 7.78
Primary

Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg

72-hour fasting Day 3 Leptin dose 0.01 mg/kg

Time frame: 3 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgc(MAX)2.60 NG/MLStandard Deviation 0.59
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)1.42 NG/MLStandard Deviation 0.72
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgc(MAX)4.21 NG/MLStandard Deviation 1.17
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)3.32 NG/MLStandard Deviation 1.21
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgc(MAX)4.62 NG/MLStandard Deviation 1.6
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)3.53 NG/MLStandard Deviation 1.26
Primary

Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg

72-hour fasting Day 3 Leptin dose 0.1 mg/kg

Time frame: 3 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgc(MAX)33.88 NG/MLStandard Deviation 9.38
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)1.69 NG/MLStandard Deviation 0.89
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgc(MAX)78.43 NG/MLStandard Deviation 14.71
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)5.92 NG/MLStandard Deviation 1.33
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgc(MAX)106.4 NG/MLStandard Deviation 36.7
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)5.36 NG/MLStandard Deviation 1.89
Primary

Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg

72-hour fasting Day 3 Leptin dose 0.3 mg/kg

Time frame: 3 DAY

ArmMeasureGroupValue (MEAN)Dispersion
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgc(MAX)88.39 NG/MLStandard Deviation 32.13
5 LEAN MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)1.62 NG/MLStandard Deviation 0.64
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgc(MAX)301.6 NG/MLStandard Deviation 86.8
5 OBESE MEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)13.72 NG/MLStandard Deviation 2.97
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgc(MAX)399.6 NG/MLStandard Deviation 76.8
5 LEAN WOMEN Fasting (72 Hrs) - Leptin 0.01 mg/kgLeptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kgL0 (ENDOGENOUS LEPTIN LEVEL)6.95 NG/MLStandard Deviation 1.05
Secondary

Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)

Data were collected neither in Fed nor in Fasting state for the different doses of leptin

Time frame: day 3 of fasting and day 1 of fed state

Secondary

Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)

Data were collected neither in Fed nor in Fasting state for the different doses of leptin

Time frame: 1 DAY or DAY 3

Secondary

Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)

Data were collected neither in Fed nor in Fasting state for the different doses of leptin

Time frame: 1 DAY or DAY 3

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026