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Trial record 26 of 31 for:    Metreleptin

Leptin in the Maintenance of Reduced Body Weight

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01155180
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: Leptin
Drug: Placebo
Enrollment 24
Recruitment Details Subjects who have successfully completed 1of the 4 hospital-based participating weight loss programs (Boston Medical Center, Tufts Medical Center, Massachusetts General Hospital, Beth Israel Deaconess Medical Center (BIDMC)-Joslin Center) & have achieved a >8% (average 10%, range 8-14%) weight loss will be invited to participate in the study.
Pre-assignment Details  
Arm/Group Title Leptin Placebo
Hide Arm/Group Description

We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Leptin: Hormone - daily self injections for 6 months

We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Placebo: Placebo

Period Title: Overall Study
Started 18 6
Completed 18 6
Not Completed 0 0
Arm/Group Title Leptin Placebo Total
Hide Arm/Group Description

We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Leptin: Hormone - daily self injections for 6 months

We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Placebo: Placebo-daily self injections for 6 months

Total of all reporting groups
Overall Number of Baseline Participants 18 6 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
years Number Analyzed 18 participants 6 participants 24 participants
32
(23 to 41)
45.5
(24 to 67)
45
(23 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 6 participants 24 participants
Female
9
  50.0%
6
 100.0%
15
  62.5%
Male
9
  50.0%
0
   0.0%
9
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 6 participants 24 participants
18 6 24
1.Primary Outcome
Title Percent Change From Baseline in Body Weight at 6 Months
Hide Description Body weight was recorded to the nearest 0.1 kg at baseline and at 6 months after randomization. Then the percentage change was calculated.
Time Frame baseline and 6 months after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Leptin Placebo
Hide Arm/Group Description:

We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Leptin: Hormone - daily self injections for 6 months

We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Placebo: Placebo

Overall Number of Participants Analyzed 18 6
Mean (Standard Error)
Unit of Measure: percentage change
10.2  (1.7) 12.7  (1.2)
Time Frame 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Leptin Placebo
Hide Arm/Group Description

We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Leptin: Hormone - daily self injections for 6 months

We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Placebo: Placebo

All-Cause Mortality
Leptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Leptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Leptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/6 (0.00%) 
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: Dr. Christos Manztoros
Organization: Beth Israel Deaconess Medical Center
Phone: 617-667-8630
Responsible Party: Christos Mantzoros, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01155180     History of Changes
Other Study ID Numbers: 2008P000190
R01DK079929 ( U.S. NIH Grant/Contract )
First Submitted: June 16, 2010
First Posted: July 1, 2010
Results First Submitted: December 22, 2015
Results First Posted: April 7, 2017
Last Update Posted: April 7, 2017