NCT00896298

Brief Summary

Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects with lipodystrophy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

March 5, 2019

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

8.6 years

First QC Date

May 8, 2009

Results QC Date

January 15, 2019

Last Update Submit

March 25, 2024

Conditions

HypoleptinemiaGeneralized LipodystrophyPartial LipodystrophyInsulin Resistance

Keywords

LipodystrophyInsulin secretory response

Outcome Measures

Primary Outcomes (2)

  • Fasting Serum Triglycerides

    4 months

  • HbA1c

    4 months

Secondary Outcomes (2)

  • Fasting Serum Glucose

    4 months

  • Body Weight

    4 months

Study Arms (2)

1 Leptin

ACTIVE COMPARATOR

Active Comparator for 4 months, then for 8 months.

Drug: Leptin

2 Sugar pill

PLACEBO COMPARATOR

Placebo for 4 months, then active comparator for 8 months.

Drug: Placebo

Interventions

LeptinDRUG

Leptin injected subcutaneously twice a day, to be administered at 100% of the estimated replacement dose during the first month, which is a dosage of 0.03mg/kg for female children, 0.04mg/kg for adult females, and0.02 mg/kg for all males, and then at 200% subsequently, or placebo.

Also known as: Recombinant-methionyl Human Leptin., r-metHuLeptin
1 Leptin
PlaceboDRUG

Sugar pill

2 Sugar pill

Eligibility Criteria

Age6 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 6 years
  • Partial and generalized lipodystrophy
  • Serum leptin levels less than the 7th percentile of normal values reported by the 3rd National Health and Nutrition Examination survey (less than 7.0 ng/mL in females and less than 3/0 ng/mL in males)
  • Presence of at least one of the following metabolic abnormalities:
  • Type 2 Diabetes Mellitus
  • Fasting serum insulin \>20 uU/mL
  • Fasting serum triglycerides \> 300 mg/dL
  • Previous participation in leptin trial (Amgen 991265, GCRC 660) - for Part B of the Study.

You may not qualify if:

  • Known liver disease due to causes other than non-alcoholic steatohepatitis.
  • Hematocrit of less than 30%.
  • Current alcohol or substance abuse.
  • Use of anorexigenic drugs, anabolic steroids, GH and thiazolidinediones
  • Active tuberculosis
  • Psychiatric disorder impeding competence or compliance
  • Malignancies
  • HIV infection
  • Subjects who have a known hypersensitivity to E. Coli derived proteins
  • Other condition, which in the opinion of the clinical investigators would impede completion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Lipodystrophy, Congenital GeneralizedLipodystrophy, Partial, AcquiredInsulin ResistanceLipodystrophy

Interventions

Leptinrecombinant methionyl human leptin

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

AdipokinesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Dr. Abhimanyu Garg
Organization
UT Southwestern Medical Center
abhimanyu.garg@utsouthwestern.edu
214-648-2895

Study Officials

  • Abhimanyu Garg, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Division Nutrition and Metabolic Diseases, Professor Internal Medicine

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 11, 2009

Study Start

April 1, 2006

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 27, 2024

Results First Posted

March 5, 2019

Record last verified: 2024-03

Locations

US(1)