DRUG
metreleptin
metreleptin injection
Status
Completed
Phase
Not applicable
Enrollment
41
Locations
5
Results
Not posted
Publications
4
Study summary
This is an open-label study to provide metreleptin for the treatment of diabetes mellitus and/or hypertriglyceridemia associated with lipodystrophy. This study intends to provide guidance to investigators with respect to identification of appropriate subjects for metreleptin treatment, guidance on metreleptin dosing, and collection of safety and efficacy data following metreleptin treatment in this population
Interventions
DRUG
metreleptin injection
Timeline
First posted
May 14, 2008
Study start
Mar 2009
Primary completion
Jan 2015
Study completion
Jan 2015
Results posted
Not reported
Registry updated
Apr 30, 2015
Outcomes
To provide metreleptin, an investigational medication, under a treatment protocol to subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia
Time frame · open ended
To monitor the safety and tolerability of metreleptin in subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia
Time frame · open ended
Information on the efficacy of metreleptin as assessed by its effects on fasting triglyceride concentrations, HbA1c, and fasting glucose concentrations in subjects with lipodystrophy that is associated with diabetes mellitus and/or hypertriglyceridemia
Time frame · open ended
Eligibility
Inclusion Criteria: * Is male or female ≥5 years old * If female of childbearing potential (including perimenopausal women who have had a menstrual period within one year): 1. Not breastfeeding 2. Negative pregnancy test result 3. Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of the study (Double barrier methods including the use of female diaphragm and male condom with spermicide can also be used.) * Has physician-confirmed lipodystrophy as defined by evidence of generalized (whole body) or partial (limbs) loss of body fat outside the range of normal variation * Has been diagnosed with at least one of the following 2 metabolic disorders: 1. Diabetes Mellitus 2. Hypertriglyceridemia as defined by fasting triglyceride concentrations \>200 mg/dL * If ≥18 years of age, is able to read, understand, and sign the Informed Consent Form (ICF) and an Authorization to Use and Disclose Protected Health Information form, communicate with the investigator, and understand and comply with protocol requirements * If \<18 years of age, has a parent or legal guardian to read and understand the ICF and Child Assent Form, communicate with the investigator, and understand and comply with protocol requirements. Adolescent subjects must also read and understand the Child Assent Form; if the child is too young or unable to read, then the Child Assent Form must be explained to the child. Exclusion Criteria: * Has been diagnosed with HIV infection * Has known infectious liver disease * Has known allergies to E. coli-derived proteins or hypersensitivity to any component of study treatment
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Santa Barbara, California, United States
Research Site
Chicago, Illinois, United States
Research Site
Ann Arbor, Michigan, United States
Local Institution
Reno, Nevada, United States
Research Site
Greenville, North Carolina, United States
Publications
Related trials
Gabriella Milos · Anorexia Nervosa
Phase 2
Recruiting
50
2026-07
Regeneron · Generalized Lipodystrophy
Phase 3
Completed
9
2026-07
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Diabetes · Lipodystrophy
Phase 2
Active, not recruiting
29
2026-07
Amryt Pharma · Generalized Lipodystrophy
Phase 3
Terminated
1
2026-07
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Lipodystrophy · Diabetes
Phase 3
Active, not recruiting
24
2026-07
Chiesi Farmaceutici S.p.A. · Generalised Lipodystrophy · Partial Lipodystrophy
Not applicable
Recruiting
100
2026-07
Chiesi Farmaceutici S.p.A. · Familial Partial Lipodystrophy
Phase 3
Recruiting
24
2026-07
Chiesi Farmaceutici S.p.A. · Partial Lipodystrophy
Phase 3
Active, not recruiting
69
2026-06
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.