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Lipodystrophy clinical trials

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NCT ID: NCT05088460 Terminated - Clinical trials for Familial Partial Lipodystrophy

A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)

LEAP
Start date: February 28, 2022
Phase: Phase 2
Study type: Interventional

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 evaluated for patients in Cohort A only: - To evaluate the effect of REGN4461 on fasting triglycerides (TG) in patients with elevated baseline fasting TG - To evaluate the effect of REGN4461 on hyperglycemia in patients with elevated baseline Hemoglobin A1c (HbA1c) The following secondary objectives of the study will be evaluated for Cohort B and for the combined set of Cohorts A plus B: - To evaluate the effect of REGN4461 on fasting TG levels in patients with hypertriglyceridemia - To evaluate the effect of REGN4461 on glycemic control in patients with hyperglycemia The following secondary objectives of the study will be evaluated for Cohorts A and B separately, and for the combined set of Cohorts A plus B: - To evaluate the effect of REGN4461 on liver fat in patients with hepatic steatosis - To evaluate the effect of REGN4461 on hunger - To evaluate safety and tolerability of REGN4461 - To characterize the concentration profile of REGN4461 over time - To assess immunogenicity to REGN4461

NCT ID: NCT02527343 Terminated - Clinical trials for Familial Partial Lipodystrophy

The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy

Start date: December 28, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

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). Following the randomized treatment period, participants who did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period and participants who were entered in the OLE period continued to receive volanesorsen for another 52 weeks (Weeks 53 to 104). Following the Week 104 visit of the OLE period, participants had an option of continued dosing for up to an additional 52 weeks (Week 105 to 156). Participants who did not enter the OLE period went straight to a 13-week post-treatment follow-up period. Following the Week 104 OLE period, participants were entered a 13-week post-treatment follow-up period, if they did not choose the option for continued dosing.

NCT ID: NCT02492997 Terminated - Lipodystrophy Clinical Trials

Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference

Start date: May 14, 2015
Phase: N/A
Study type: Interventional

The octipolar applicator is intended for circumference reduction treatment by reduction of adipose size and enhancement of collagen synthesis as the result thermal and non-thermal collagen stimulation. This trial is intended to evaluate the effect of radio frequency (RF) and pulsed electromagnetic fields (PEMF) treatment on circumference reduction.

NCT ID: NCT01329744 Terminated - HIV Lipodystrophy Clinical Trials

Effects of IGF-I in HIV Metabolic Disease

Start date: June 2011
Phase: Phase 1
Study type: Interventional

This study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease.

NCT ID: NCT00148850 Terminated - HIV Infections Clinical Trials

Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients

Start date: February 2003
Phase: Phase 3
Study type: Interventional

The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.

NCT ID: NCT00126308 Terminated - HIV Infections Clinical Trials

Facial Lipoatrophy Trial: Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial Lipoatrophy

Start date: November 2005
Phase: Phase 4
Study type: Interventional

This is a multi-centre, open-label, 96 week study to evaluate the safety, tolerability and extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep subcutaneous injections of poly-L-lactic acid (PLA). Subjects will receive 4 treatments of PLA approximately every 2nd week, either at trial entry or following a delay period of 24 weeks.

NCT ID: NCT00122668 Terminated - HIV Infections Clinical Trials

Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients

Start date: November 2003
Phase: Phase 4
Study type: Interventional

The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).

NCT ID: NCT00122655 Terminated - HIV Infections Clinical Trials

Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy

Start date: January 2001
Phase: Phase 4
Study type: Interventional

The aim of this trial is to evaluate the impact on fat distribution of switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression. Maintenance of virological suppression and immunological factors are also assessed.

NCT ID: NCT00001219 Terminated - Tumors Clinical Trials

Comparing Magnetic Resonance Imaging/Spectroscopy Techniques

Start date: June 18, 1987
Phase:
Study type: Observational

Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) are diagnostic tests that allow researchers to look at different chemical properties of tissue. Magnetic resonance imaging and spectroscopy studies can be used to gather or evaluate information about various aspects of patient s bodies or to monitor changes in the biochemistry and physiology of patient s bodies. Unlike other diagnostic techniques (CT scan and PET scan) MRI and MRS do not use ionizing radiation. Some studies have shown that MRI is more effective at distinguishing normal parts of the anatomy from abnormal anatomy, especially in the brain. MRI has become the diagnostic test of choice for evaluating patient with multiple sclerosis. The purpose of this study is to evaluate normal volunteers and patients with a variety of diseases with magnetic resonance imaging. Researchers will attempt different magnetic resonance imaging methods and techniques as well as different levels of magnetic strength.