Nonalcoholic Steatohepatitis Clinical Trial
Official title:
Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy
This study involves research about an investigational medicine called metreleptin. The reason for this study is to find out how metreleptin can improve non-alcoholic steatohepatitis or nonalcoholic fatty liver disease associated with lipodystrophy, a rare disorder associated with abnormal loss of the body's fat tissue. In this study, metreleptin is considered to be investigational for the treatment of lipodystrophy. Metreleptin will be given via injections under the skin. We plan to continue therapy for a period of one year and evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body).
The goal is to test the efficacy of restorative leptin therapy on the degree of hepatic
steatosis and on amelioration of pathological features of NASH/NAFLD. In addition, the study
will evaluate the impact of leptin therapy on total body insulin sensitivity and lipid
levels as well as energy expenditure. In order to accomplish this aim, we now propose an
efficacy study with recombinant human leptin therapy in patients with all forms of
lipodystrophy who also have NASH/NAFLD.
1. AIM 1: To determine the efficacy of leptin in promoting amelioration of body
composition, hepatic steatosis and histopathological scores in patients with all forms
of lipodystrophy and NAFLD/NASH. We will conduct a 1 year, open-label study, to assess
the metabolic effects of recombinant human leptin (METRELEPTIN, AztraZeneca,
Wilmington, DE). The primary outcome measure will be NASH scores. We will also explore
body weight, insulin sensitivity, glucose and lipid control, body composition, and free
fatty acid levels.
2. AIM 2: To Investigate molecular effects of leptin therapy. In parallel to our
preliminary studies, gene expression will be performed on individuals participating in
Aim 1 at baseline and following 1 year of leptin. We will combine this with measures of
liver metabolite levels to provide novel insights into alterations in metabolism that
occur secondary to leptin therapy. We will also measure plasma metabolites at baseline
and after 2 (optional), 24 and 48 weeks of therapy to assess the dynamic changes
induced by leptin and correlate these changes with phenotypic measures.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03375008 -
Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)
|
N/A | |
| Recruiting |
NCT05979779 -
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
|
Phase 2 | |
| Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
| Completed |
NCT02654977 -
CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy
|
Phase 2 | |
| Recruiting |
NCT05211284 -
Saroglitazar Magnesium 4 mg for NASH in People Living With HIV in the US
|
Phase 2 | |
| Completed |
NCT02421094 -
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
|
Phase 2 | |
| Completed |
NCT01205087 -
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome
|
Phase 2 | |
| Recruiting |
NCT00152711 -
Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis
|
N/A | |
| Completed |
NCT02217475 -
Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
|
Phase 2 | |
| Completed |
NCT04031729 -
Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT03674476 -
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
|
Phase 1 | |
| Recruiting |
NCT03725631 -
Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD
|
N/A | |
| Terminated |
NCT04565717 -
A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
|
Phase 1 | |
| Active, not recruiting |
NCT05084404 -
Efficacy and Safety of Guanabenz for Nonalcoholic Fatty Liver Disease
|
Phase 2 | |
| Active, not recruiting |
NCT02574325 -
A Study to Assess ARI-3037MO on Hepatic Fat Metabolism in Patients With Dysglycemia and Evidence of Hepatic Steatosis
|
Phase 2 | |
| Terminated |
NCT00878592 -
Effect of Dietary and Life Style Modification on Post Liver Transplant Obesity
|
N/A | |
| Recruiting |
NCT02148471 -
Fatty Acids, Genes and Microbiota in Fatty Liver
|
N/A | |
| Completed |
NCT00227110 -
Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)
|
Phase 4 | |
| Completed |
NCT03656744 -
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
|
Phase 2 | |
| Completed |
NCT03068078 -
A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes
|
N/A |