Phase 1 N=15 Diagnostic

Pharmacokinetics of Leptin Administration During Fasting

Energy Deficiency Due to Short-term Fasting

Bottom Line

View on ClinicalTrials.gov: NCT00140205 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg — 1.93; 2.75; 2.99; 2.00 HR

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: r-metHuLeptin (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Jun 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg	1.93; 2.75; 2.99; 2.00; 3.00; 2.80	—
PRIMARY Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg	2.60; 4.21; 4.62; 1.42; 3.32; 3.53	—
PRIMARY Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.01 mg/kg	12.27; 35.43; 47.81	—
PRIMARY Leptin Pharmacokinetic Parameters TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg	1.82; 3.10; 1.73; 3.20; 4.00; 3.00	—
PRIMARY Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg	33.88; 78.43; 106.4; 1.69; 5.92; 5.36	—
PRIMARY Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.1 mg/kg	206.9; 778.2; 676.5	—
PRIMARY Leptin Pharmacokinetic Parameters - TIME(T1/2) DAY 3 / TMAX DAY 3 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg	1.98; 2.40; 1.92; 3.80; 3.40; 3.80	—
PRIMARY Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg	88.39; 301.6; 399.6; 1.62; 13.72; 6.95	—
PRIMARY Leptin Pharmacokinetics Parameters - AUC 72-hour Fasting Day 3 Leptin Dose 0.3 mg/kg	747.3; 2717; 2738	—
PRIMARY Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.3 mg/kg	2.94; 3.69; 2.91; 3.60; 3.40; 2.80	—
PRIMARY Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.3 mg/kg	168.7; 254.3; 440.7; 2.97; 16.24; 12.60	—
PRIMARY Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.3 mg/kg	1243; 2948; 3300	—
PRIMARY Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.01 mg/kg	2.84; 4.71; 3.08; 3.00; 6.20; 2.80	—
PRIMARY Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.01 mg/kg	5.97; 7.91; 14.51; 2.32; 12.67; 15.54	—
PRIMARY Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.01 mg/kg	33.18; 113.9; 110.5	—
PRIMARY Leptin Pharmacokinetic Parameters - TIME(T1/2) / TMAX 24-hour Fed Leptin Dose 0.1 mg/kg	2.89; 4.72; 2.08; 3.00; 4.60; 3.20	—
PRIMARY Leptin Pharmacokinetics Parameters - c(MAX) / L0 (ENDOGENOUS LEPTIN LEVEL) 24-hour Fed Leptin Dose 0.1 mg/kg	72.56; 77.26; 107.4; 2.11; 15.49; 14.36	—
PRIMARY Leptin Pharmacokinetics Parameters - AUC 24-hour Fed Leptin Dose 0.1 mg/kg	507.4; 1051; 620.2	—
SECONDARY Cytokine Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)	—	—
SECONDARY Neuroendocrine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)	—	—
SECONDARY Adipokine Hormone Levels 24h Fed or 72h Fasting for All Different Leptin Doses (0,01-0,1-0,3 mg/kg)	—	—

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.

Eligibility Criteria

Inclusion Criteria

healthy men with body mass indices (BMI) 27 kg/m2
healthy lean 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00140205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.