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Last Updated: May 18, 2024

CLINICAL TRIALS PROFILE FOR METRELEPTIN


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All Clinical Trials for metreleptin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00025883 ↗ Leptin to Treat Lipodystrophy Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2001-10-01 This study will evaluate the safety and effectiveness of leptin replacement therapy in patients with lipodystrophy (also called lipoatrophy). Patients have a total or partial loss of fat cells. They also lack the hormone leptin, which is produced by fat cells. The leptin deficiency usually causes high blood lipid (fat) levels and insulin resistance that may lead to diabetes. Patients may have hormone imbalances, fertility problems, large appetite, and liver disease due to fat accumulation. Patients age greater than or equal to 6 months with significant lipodystrophy may be eligible for this study. Participants will be admitted to the NIH Clinical Center for 10 days for the following studies before beginning 12 months of leptin therapy: - Insulin tolerance test - Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies. - Fasting blood tests - Resting metabolic rate - Magnetic resonance imaging of the liver and other organs, and of muscle and fat. - Pelvic ultrasound in women to detect ovarian cysts. - Estimation of body fat - Oral glucose tolerance test - Intravenous glucose tolerance test - Appetite level and food intake - Hormone function tests - Questionnaires to assess activity and mood - 24-hour urine collections Additional studies may include blood tests for genetic studies of lipodystrophy, a muscle biopsy to study muscle proteins involved in regulating energy expenditure before and after leptin replacement, and examination of a surgical specimen (if available) to study molecules that may be involved in energy storage and use. When the above tests are completed, leptin therapy begins. The drug is injected under the skin twice a day for 4 months and then once a day, if feasible. The dose is increased at the 1- and 2-month visits. Follow-up visits at 1, 2, 4, 6, 8 and 12 months after therapy starts include a physical examination, blood tests and a meeting with a dietitian. At the end of 12 months, all baseline studies described above are repeated. Patients record their symptoms weekly throughout the study. Those with diabetes measure their blood glucose levels daily before each meal and at bedtime.
NCT00085982 ↗ Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance Recruiting National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-08-21 Study Description: Patients with mutations of the insulin receptor have diabetes that is challenging to control withconventional therapies, leading to early morbidity and mortality. We hypothesize that recombinant leptin (metrel eptin) in these patients will improve glycemia control. Objectives: Primary Objective: To determine if 1 year of metreleptin will improve glycemia control in patients with genetic defects of the insulin receptor. Secondary Objectives: To determine mechanisms by which metreleptin improves glycemia. Endpoints: Primary Endpoint: Hemoglobin A1c. Secondary Endpoints: fasting plasma glucose, fasting insulin/C-peptide, glucose/insulin/C-peptide area under the curve during oral glucose tolerance test. Study Population: 20 male or female patients with mutations of the insulin receptor, age (Bullet)5 years, at the NIH Clinical Center. Description of Sites/Facilities Enrolling Participants: Description of Study Intervention: NIH Clinical Center Open label study of metreleptin, 0.2 mg/kg/day (max dose 0.24 mg/kg/day).
NCT00130117 ↗ Study of Leptin for the Treatment of Hypothalamic Amenorrhea Completed Amgen Phase 2 2010-04-01 The purpose of this study is to determine whether administration of an investigational medication called leptin (r-metHuLeptin) in replacement doses can improve bone health, reproductive function, hormone levels, immune function, and overall sense of well-being in women with hypothalamic (exercise-induced) amenorrhea (HA) who are being treated with oral contraceptive pills (OCPs), compared to placebo. Women with hypothalamic amenorrhea have low leptin levels. This study is based on the hypothesis that the relative leptin deficiency in women with hypothalamic (exercise-induced) amenorrhea may be the reason for the lack of menstrual cycles, hormone abnormalities, and bone loss associated with this condition.
NCT00130117 ↗ Study of Leptin for the Treatment of Hypothalamic Amenorrhea Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 2010-04-01 The purpose of this study is to determine whether administration of an investigational medication called leptin (r-metHuLeptin) in replacement doses can improve bone health, reproductive function, hormone levels, immune function, and overall sense of well-being in women with hypothalamic (exercise-induced) amenorrhea (HA) who are being treated with oral contraceptive pills (OCPs), compared to placebo. Women with hypothalamic amenorrhea have low leptin levels. This study is based on the hypothesis that the relative leptin deficiency in women with hypothalamic (exercise-induced) amenorrhea may be the reason for the lack of menstrual cycles, hormone abnormalities, and bone loss associated with this condition.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for metreleptin

Condition Name

Condition Name for metreleptin
Intervention Trials
Obesity 8
Lipodystrophy 6
Diabetes 4
Overweight 3
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Condition MeSH

Condition MeSH for metreleptin
Intervention Trials
Lipodystrophy 11
Body Weight 4
Overweight 3
Non-alcoholic Fatty Liver Disease 3
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Clinical Trial Locations for metreleptin

Trials by Country

Trials by Country for metreleptin
Location Trials
United States 104
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Trials by US State

Trials by US State for metreleptin
Location Trials
Michigan 8
Texas 7
Massachusetts 6
Florida 6
Maryland 5
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Clinical Trial Progress for metreleptin

Clinical Trial Phase

Clinical Trial Phase for metreleptin
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 15
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Clinical Trial Status

Clinical Trial Status for metreleptin
Clinical Trial Phase Trials
Completed 16
Terminated 3
Not yet recruiting 2
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Clinical Trial Sponsors for metreleptin

Sponsor Name

Sponsor Name for metreleptin
Sponsor Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 13
University of Michigan 5
AstraZeneca 4
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Sponsor Type

Sponsor Type for metreleptin
Sponsor Trials
Other 19
NIH 17
Industry 14
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