Clinical trials: Lipodystrophy
Lipodystrophy, Diabetes
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Background: Generalized lipodystrophy can cause high blood fat levels and resistance to insulin. This can lead to health problems including diabetes.
- Conditions
- Lipodystrophy, Diabetes, Hyperlipidemia
- Trial name
- NCT02262832
- Testing
- Metreleptin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Generalized Lipodystrophy
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
This study is researching a new drug called mibavademab (called "study drug"). The study involves participants with a condition called Generalized Lipodystrophy (GLD).
- Trial name
- LAGO (NCT07220785)
- Testing
- Mibavademab
- Where
- 9 sites in United States, Brazil and 1 more
- Volunteers
- 28 people
- Sponsor
- Regeneron Pharmaceuticals
Diabetes, Lipodystrophy
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Background: Partial lipodystrophy can cause high blood fat levels and resistance to insulin. This can lead to health problems including diabetes.
- Conditions
- Diabetes, Lipodystrophy, Hyperlipidemia
- Trial name
- NCT02262806
- Testing
- Metreleptin
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Expanded Access for Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy
This is an expanded access designed to provide metreleptin for the treatment of diabetes mellitus and/or hypertriglyceridemia associated with lipodystrophy.
- Trial name
- NCT00677313
- Testing
- metreleptin
- Sponsor
- Bristol-Myers Squibb
Lipodystrophy
Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy
Background: Lipodystrophy is a health problem in which the body does not have enough fat tissue. People with lipodystrophy may not make enough of the hormone leptin. Leptin regulates hunger. Low leptin levels trigger hunger.
- Trial name
- NCT05419037
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Generalized Lipodystrophy
A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)
This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months.
- Trial name
- NCT06548100
- Testing
- mibavademab
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Regeneron Pharmaceuticals
Generalized Lipodystrophy
Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
This is an open-label, Phase 3b study to evaluate effectiveness, safety and pharmacokinetic parameters of metreleptin in patients under 6 years of age with generalised lipodystrophy and associated diabetes mellitus and/or…
- Trial name
- NCT06502990
- Testing
- Metreleptin
- Where
- 12 sites in Belgium, France and 2 more
- Volunteers
- 1 people
- Sponsor
- Amryt Pharma
Generalised Lipodystrophy, Partial Lipodystrophy
MEASuRE: Metreleptin Effectiveness And Safety Registry
The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA.
- Trial name
- MEASuRE (NCT02325674)
- Testing
- Metreleptin
- Where
- 28 sites in United States, France and 3 more
- Volunteers
- 100 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Familial Partial Lipodystrophy
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
This Phase 3 study is an Open Label Extension of the APG-20 Study To Evaluate the Long-term Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects with Partial Lipodystrophy
- Trial name
- NCT06679270
- Testing
- Metreleptin
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Generalized Lipodystrophy
Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
The primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on…
- Trial name
- NCT04159415
- Testing
- Low-Dose REGN4461, High-dose REGN4461
- Where
- 8 sites in United States, Peru and 2 more
- Volunteers
- 16 people
- Sponsor
- Regeneron Pharmaceuticals
Partial Lipodystrophy
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
- Trial name
- METRE-PL (NCT05164341)
- Testing
- metreleptin
- Where
- 31 sites in United States, Belgium and 7 more
- Volunteers
- 69 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Lipodystrophy (Genetic or Acquired, Non HIV)
The LD Lync Study - Natural History Study of Lipodystrophy Syndromes
Genetic lipodystrophy syndromes are extremely rare, orphan diseases with overall estimated prevalence of less than 2,000 in the United States.
- Trial name
- NCT03087253
- Where
- 4 sites in United States, Brazil and 1 more
- Volunteers
- 500 people
- Sponsor
- University of Michigan
Lipodystrophy Acquired, Type1diabetes
Cyclophosphamide in the Treatment of Associated Acquired Lipodystrophy Syndrome With Type 1 Diabetes
This study evaluates the change of insulin resistance and glucose metabolism of patients with panniculitis associated acquired lipodystrophy syndrome and type 1 diabetes with the treatment of cyclophosphamide.
- Trial name
- NCT03936829
- Testing
- Cyclophosphamide
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Children's Hospital of Fudan University
Lipodystrophy, Generalized Lipodystrophy (GLD)
Expanded Access to REGN4461 for Patients With Diseases Associated With Deficient Leptin Signaling
Provide Expanded Access to REGN4461 for patients with diseases associated with deficient leptin signaling.
- Conditions
- Lipodystrophy, Generalized Lipodystrophy (GLD), Monogenic Obesity (MOB)
- Trial name
- NCT04710056
- Testing
- REGN4461
- Sponsor
- Regeneron Pharmaceuticals
HIV, Lipodystrophy
The Cleveland Cardiometabolic Cohort
In this observational study, the investigators will examine the changes in body composition in HIV-infected subjects before and after initiation of HIV treatment, and look at the correlations with changes in cardiometabolic…
- Trial name
- NCT03059121
- Testing
- Dual-energy X-ray absorptiometry
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University Hospitals Cleveland Medical Center
Familial Partial Lipodystrophy Type 2
Study of Cortisol Metabolism in Familial Partial Lipodystrophy Type 2
Familial partial lipodystrophic syndromes are characterized by an increase in visceral adipose tissue and an atrophy of subcutaneous adipose tissue.
- Trial name
- LIPOCORT (NCT04845165)
- Testing
- Biopsy
- Where
- France
- Volunteers
- 25 people
- Sponsor
- University Hospital, Lille
Lipodystrophy Acquired, Lipodystrophy Congenital
Registry for Patients With Lipodystrophy
Given the lack of knowledge on lipodystrophies, the medical and social responsibility for the persons affected by it calls for the monitoring of the progression over long periods of time.
- Trial name
- ECLip Registry (NCT03553420)
- Where
- 28 sites in Austria, France and 14 more
- Volunteers
- 5,000 people
- Sponsor
- University of Ulm
Generalized Lipodystrophy
Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (MYALEPT Prescribing…
- Trial name
- NCT04026178
- Testing
- Metreleptin
- Where
- 8 sites in United States
- Volunteers
- 11 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Type 1 Diabetes Mellitus
The Skin Barrier in Users of Diabetes Devices
Diabetes technology (insulin pumps and continuous glucose monitoring) have become standard of care in children with type 1 diabetes.
- Trial name
- StenoLin (NCT06856954)
- Where
- Sweden
- Volunteers
- 150 people
- Sponsor
- Jannet Svensson
Hepatic Steatosis
Cholic Acid for Hepatic Steatosis in Lipodystrophy
To evaluate the efficacy and safety of cholic acid therapy in treating lipodystrophy patients with hepatic steatosis. This is a randomized, double-blind, placebo-controlled cross-over study.
- Trial name
- NCT00457639
- Testing
- Cholic Acid
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Texas Southwestern Medical Center