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Trial record 7 of 23 for:    " December 21, 2011":" January 20, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome

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ClinicalTrials.gov Identifier: NCT01511016
Recruitment Status : Completed
First Posted : January 18, 2012
Results First Posted : January 27, 2016
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Ashok Balasubramanyam, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV Lipodystrophy
Interventions Drug: Human recombinant leptin ("metreleptin")
Drug: Placebo
Enrollment 17
Recruitment Details HIV-positive subjects meeting the entry criteria were recruited from March, 2003 until November, 2010 from the clinics of Harris County Hospital District, and Legacy Community Health Center, Houston.
Pre-assignment Details If a potential study subject was already taking a lipid lowering medication at the time of screening but was otherwise eligible for the study, he/she was invited to stop the medication for 6 weeks, at the end of which the fasting triglyceride level was re-measured to gauge eligibility.
Arm/Group Title Placebo Injection Human Recombinant Leptin (Metreleptin)
Hide Arm/Group Description

Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.

Period Title: Overall Study
Started 8 9
Completed 6 7
Not Completed 2 2
Arm/Group Title Placebo Injection Human Recombinant Leptin (Metreleptin) Total
Hide Arm/Group Description

Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.

Total of all reporting groups
Overall Number of Baseline Participants 8 9 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
9
 100.0%
17
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 17 participants
49.1  (6.8) 44.9  (7.8) 46.9  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
9
 100.0%
17
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 9 participants 17 participants
8 9 17
1.Primary Outcome
Title Rate of Total Lipolysis
Hide Description Rate of total lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate
Time Frame 4 months after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects in each group were analyzed and compared after 4 months of treatment.
Arm/Group Title Placebo Injection Human Recombinant Leptin (Metreleptin)
Hide Arm/Group Description:

Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.

Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: mmol FFA/kg/h
0.649  (0.073) 0.767  (0.137)
2.Primary Outcome
Title Rate of Net Lipolysis
Hide Description Rate of net lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate
Time Frame 4 months after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects in each group were analyzed and compared after 4 months of treatment
Arm/Group Title Placebo Injection Human Recombinant Leptin (Metreleptin)
Hide Arm/Group Description:

Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.

Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: mmol FFA/kg/h
0.386  (.074) 0.508  (.106)
3.Secondary Outcome
Title Rates of Fatty Acid Oxidation
Hide Description Rates of fatty acid oxidation were measured in breath samples following stable isotope infusions of 13C-labeled palmitate.
Time Frame 4 months after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of subjects in each group remaining at the end of 4 months of treatment.
Arm/Group Title Placebo Injection Human Recombinant Leptin (Metreleptin)
Hide Arm/Group Description:

Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.

Overall Number of Participants Analyzed 6 8
Mean (Standard Error)
Unit of Measure: mmol FFA/kg/h
0.239  (0.023) 0.214  (0.040)
4.Secondary Outcome
Title Fasting Plasma Non-HDL-C
Hide Description Fasting plasma non-HDL-cholesterol was calculated from measured total cholesterol and HDL cholesterol.
Time Frame 4 months after treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of subjects in each group remaining after 4 months of treatment.
Arm/Group Title Placebo Injection Human Recombinant Leptin (Metreleptin)
Hide Arm/Group Description:

Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.

Overall Number of Participants Analyzed 6 8
Mean (Standard Error)
Unit of Measure: mg/dL
136  (9) 127  (7)
5.Secondary Outcome
Title Glucose Levels After Glucose Challenge
Hide Description An oral glucose tolerance test was performed. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a standard clinical test of glucose tolerance. i.e., a test for diabetes and pre-diabetes. Although multiple time points are used in this test, the outcome is a single value, either a blood glucose level after 2 hours or an area-under-the-curve. In this study we are reporting the area-under-the-curve.
Time Frame 4 months after treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of subjects remaining after 4 months of treatment.
Arm/Group Title Placebo Injection Human Recombinant Leptin (Metreleptin)
Hide Arm/Group Description:

Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.

Overall Number of Participants Analyzed 4 5
Mean (Standard Error)
Unit of Measure: mg/dL
6268  (434) 6647  (514)
6.Secondary Outcome
Title Insulin Levels After Oral Glucose Challenge.
Hide Description An oral glucose tolerance test was performed to measure endogenous insulin response. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a clinical test of endogenous insulin response to glucose i.e., an endocrine test. Although multiple time points are used in this test, the outcome is a single value, i.e., an area-under-the-curve for insulin.
Time Frame 4 months after treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of subjects remaining after 4 months of treatment.
Arm/Group Title Placebo Injection Human Recombinant Leptin (Metreleptin)
Hide Arm/Group Description:

Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.

Overall Number of Participants Analyzed 4 5
Mean (Standard Error)
Unit of Measure: microU/mL
1580  (954) 2868  (890)
Time Frame The duration of the study for each subject was 4 months. However, due to slow recruitment the entire study took place over approximately 4 years; therefore the average duration of subject follow-up for Adverse Events was approximately 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Injection Human Recombinant Leptin (Metreleptin)
Hide Arm/Group Description

Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.

Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.

Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.

Human recombinant leptin ("metreleptin") : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.

All-Cause Mortality
Placebo Injection Human Recombinant Leptin (Metreleptin)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Injection Human Recombinant Leptin (Metreleptin)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      2/9 (22.22%)    
Metabolism and nutrition disorders     
Hyperthyroidism   1/8 (12.50%)  1 0/9 (0.00%)  0
Weight loss   0/8 (0.00%)  0 2/9 (22.22%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Injection Human Recombinant Leptin (Metreleptin)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/9 (0.00%)    
  1. Relatively small sample size.
  2. Early drop-out of 3 subjects (2 in placebo arm, 2 in metreleptin arm).
  3. Possible confounders in phenotypic hetereogeneity of HIV lipodystrophy, and differences in antiretroviral drugs.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Leanne Scott, PhD, Director of Sponsored Programs
Organization: Baylor College of Medicine
Phone: 713-798-6978
Responsible Party: Ashok Balasubramanyam, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01511016     History of Changes
Other Study ID Numbers: H-13372
First Submitted: January 11, 2012
First Posted: January 18, 2012
Results First Submitted: August 13, 2013
Results First Posted: January 27, 2016
Last Update Posted: January 27, 2016