Clinical trials: Lipodystrophy Congenital
Skin Laxity, Lipodystrophy
CONFORM: Rotational Fractional Resection for Submental Contouring
This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.
- Trial name
- NCT03407313
- Testing
- Rotational fractional resection (1.5mm diameter device)
- Where
- 6 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Recros Medica, Inc.
Familial Partial Lipodystrophy
Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL)
This is a single-center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for reduction of fasting triglycerides in participants with familial partial lipodystrophy.
- Trial name
- NCT03514420
- Testing
- AKCEA-ANGPTL3-LRx
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Akcea Therapeutics
Lipodystrophy
Lipodystrophy Connect Patient Registry
Lipodystrophy Connect is an online survey tool designed to collect demographic data and health information from individuals with Lipodystrophy.
- Trial name
- NCT02577952
- Where
- United States
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- PatientCrossroads
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
Familial Partial Lipodystrophy
The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in a randomized treatment (RT) period in participants with familial partial lipodystrophy (FPL).
- Trial name
- NCT02527343
- Testing
- volanesorsen
- Where
- 12 sites in United States, Belgium and 5 more
- Volunteers
- 40 people
- Sponsor
- Akcea Therapeutics
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
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.
Lipodystrophy, Deformities
Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
The purpose of this post-market clinical follow up study is to assess the safety and performance of Aesthetic Group cannulas. The study will evaluate the outcome of the Aesthetic Group cannulas range over a period of 1 month…
- Trial name
- NCT06089759
- Where
- 3 sites in France
- Volunteers
- 108 people
- Sponsor
- Aesthetic Group
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.
Skin Laxity, Lipodystrophy
The PREFORM Study: Rotational Fractional Resection for Submental Contouring
This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. Rotational fractional resection is used to remove loose skin and fat.
- Trial name
- NCT03966924
- Testing
- Rotational fractional resection (1.5mm Diameter Device)
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Recros Medica, Inc.
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.
Insulin Resistance - Type A, Insulin Resistance - Type B
A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 )
A multicenter, open-label, single-arm, extension study with regard to the safety and efficacy of empagliflozin in patients with refractory diabetes mellitus with insulin resistance.
- Conditions
- Insulin Resistance - Type A, Insulin Resistance - Type B, Lipoatrophic Diabetes Mellitus, Insulin Resistance Syndrome
- Trial name
- EMPIRE-02 (NCT04221152)
- Testing
- Empagliflozin Tablets
- Where
- 5 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Kobe University
Insulin Resistance - Type A, Insulin Resistance - Type B
A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance
A multicenter, open-label, single-arm study with regard to the efficacy and safety of empagliflozin in patients with refractory diabetes mellitus with insulin resistance
- Conditions
- Insulin Resistance - Type A, Insulin Resistance - Type B, Lipoatrophic Diabetes Mellitus, Insulin Resistance Syndrome
- Trial name
- EMPIRE-01 (NCT04018365)
- Testing
- Empagliflozin Tablets
- Where
- 5 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Kobe University
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
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
Lipodystrophy, Generalized Lipodystrophy (GLD)
Compassionate Use or Expanded Access of Mibavademab
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
Familial Partial Lipodystrophy, Metabolic Abnormalities
A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
Two cohorts are being studied based on leptin levels. Cohort A is composed of patients with baseline leptin <8.0 ng/mL and Cohort B is composed of patients with baseline leptin 8.0 to ≤20.0 ng/mL The primary objectives will be…
- Trial name
- LEAP (NCT05088460)
- Testing
- REGN4461
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 20 people
- Sponsor
- Regeneron Pharmaceuticals