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Showing 1–24 of 36 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Recombinant methionyl human leptin Clear all
Recruiting No phase listed Observational

Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy

NCT05419037
View directory record Official record
Conditions
Lipodystrophy
Interventions
Not listed
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
6 Months to 98 Years
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2029
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 17, 2026 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Not applicable Interventional Results available

Leptin for Abnormal Lipid Kinetics in HIV Lipodystrophy Syndrome

NCT01511016
View directory record Official record
Conditions
HIV Lipodystrophy
Interventions
Human recombinant leptin ("metreleptin"), Placebo
Drug
Lead sponsor
Baylor College of Medicine
Other
Eligibility
18 Years to 64 Years · Male only
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2011
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jan 26, 2016 · Synced Sep 23, 2026, 8:54 PM EDT
Recruiting No phase listed Observational

MEASuRE: Metreleptin Effectiveness And Safety Registry

NCT02325674
View directory record Official record
Conditions
Generalised Lipodystrophy, Partial Lipodystrophy
Interventions
Metreleptin
Drug
Lead sponsor
Chiesi Farmaceutici S.p.A.
Industry
Eligibility
Not listed
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2031
U.S. locations
16
States / cities
Birmingham, Alabama • Duarte, California • Atlanta, Georgia + 11 more
Source: ClinicalTrials.gov public record
Updated Jul 15, 2026 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Results available

Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin

NCT00819234
View directory record Official record
Conditions
Obesity
Interventions
Placebo, Pramlintide and Metreleptin
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 65 Years
Enrollment
274 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
33
States / cities
Birmingham, Alabama • Phoenix, Arkansas • Santa Rosa, California + 30 more
Source: ClinicalTrials.gov public record
Updated Apr 14, 2015 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Study of Leptin for the Treatment of Hypothalamic Amenorrhea

NCT00130117
View directory record Official record
Conditions
Amenorrhea
Interventions
r-metHuLeptin, Oral Contraceptive Pills (OCPs), Placebo
Drug · Other
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
18 Years to 35 Years · Female only
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2016
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 16, 2017 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Results available

Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)

NCT00596934
View directory record Official record
Conditions
Fatty Liver Disease, Nonalcoholic
Interventions
metreleptin
Drug
Lead sponsor
Elif Oral
Other
Eligibility
18 Years to 65 Years · Male only
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Nov 23, 2017 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Results available

Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy

NCT01679197
View directory record Official record
Conditions
Fatty Liver Disease, Nonalcoholic, Nonalcoholic Steatohepatitis, Lipodystrophy
Interventions
Metreleptin
Drug
Lead sponsor
University of Michigan
Other
Eligibility
5 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Jun 13, 2017 · Synced Sep 23, 2026, 8:54 PM EDT
Terminated Phase 1 Interventional Results available

Effects of Metreleptin in Type 1 Diabetes Mellitus

NCT01268644
View directory record Official record
Conditions
Type 1 Diabetes
Interventions
Leptin
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 50 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Aug 27, 2019 · Synced Sep 23, 2026, 8:54 PM EDT
Active, not recruiting Phase 2 Interventional

Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy

NCT02262806
View directory record Official record
Conditions
Diabetes, Lipodystrophy, Hyperlipidemia
Interventions
Metreleptin
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
6 Months to 98 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2027
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Sep 21, 2026 · Synced Sep 23, 2026, 8:54 PM EDT
Recruiting Phase 3 Interventional

Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

NCT06679270
View directory record Official record
Conditions
Familial Partial Lipodystrophy
Interventions
Metreleptin
Drug
Lead sponsor
Chiesi Farmaceutici S.p.A.
Industry
Eligibility
13 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
7
States / cities
Birmingham, Alabama • Boca Raton, Florida • Boston, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated Jul 15, 2026 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Results available

Leptin in the Maintenance of Reduced Body Weight

NCT01155180
View directory record Official record
Conditions
Obesity
Interventions
Leptin, Placebo
Drug
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
18 Years to 67 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2016
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 6, 2017 · Synced Sep 23, 2026, 8:54 PM EDT
Active, not recruiting Phase 2 Interventional Results available

Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL)

NCT05351164
View directory record Official record
Conditions
Lipomatosis, Multiple Symmetrical
Interventions
Metreleptin
Drug
Lead sponsor
University of Michigan
Other
Eligibility
Up to 60 Years
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Jun 11, 2025 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

Role of Leptin in the Neuroendocrine and Immune Response to Fasting

NCT00140231
View directory record Official record
Conditions
Fasting
Interventions
r-metHuLeptin, placebo
Drug · Other
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
18 Years to 30 Years
Enrollment
13 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2002 – 2016
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 6, 2017 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Not applicable Interventional Results available

Recombinant Human Leptin Therapy Effects on Insulin Action

NCT01207934
View directory record Official record
Conditions
Type Two Diabetes Mellitus
Interventions
placebo, low-dose leptin, high-dose leptin
Dietary Supplement · Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
25 Years to 75 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1998 – 2000
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jul 8, 2015 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Pharmacokinetics of Leptin Administration During Fasting

NCT00140205
View directory record Official record
Conditions
Energy Deficiency Due to Short-term Fasting
Interventions
r-metHuLeptin
Drug
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
18 Years to 30 Years
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2001 – 2016
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Nov 1, 2018 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Results available

Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

NCT00673387
View directory record Official record
Conditions
Overweight, Obesity
Interventions
pramlintide acetate, metreleptin, placebo-P, placebo-M
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 65 Years
Enrollment
636 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
36
States / cities
Birmingham, Alabama • Chandler, Arizona • Santa Rosa, California + 33 more
Source: ClinicalTrials.gov public record
Updated Apr 14, 2015 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2Phase 3 Interventional Results available

Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

NCT00896298
View directory record Official record
Conditions
Hypoleptinemia, Generalized Lipodystrophy, Partial Lipodystrophy, Insulin Resistance
Interventions
Leptin, Placebo
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
6 Years to 70 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2014
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Mar 26, 2024 · Synced Sep 23, 2026, 8:54 PM EDT
Completed No phase listed Observational

The Effects of Metreleptin in Congenital Leptin Deficiency

NCT04063488
View directory record Official record
Conditions
Congenital Leptin Deficiency (Disorder)
Interventions
Metreleptin
Drug
Lead sponsor
Northwestern University
Other
Eligibility
18 Years and older
Enrollment
2 participants
Timeline
2019 – 2021
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Dec 29, 2021 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Results available

A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

NCT00392925
View directory record Official record
Conditions
Overweight, Obesity
Interventions
pramlintide acetate 360 mcg, metreleptin, placebo-pramlintide 600 uL, placebo-metreleptin 1 mL, Pramlintide acetate 180 mcg
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 55 Years
Enrollment
177 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
12
States / cities
DeLand, Florida • Chicago, Illinois • Indianapolis, Indiana + 9 more
Source: ClinicalTrials.gov public record
Updated Apr 13, 2015 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers

Effects of Leptin Treatment on Weight Loss

NCT00050791
View directory record Official record
Conditions
Obesity
Interventions
Leptin, Very Low Calorie Diet
Drug · Behavioral
Lead sponsor
Rockefeller University
Other
Eligibility
20 Years to 45 Years · Female only
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2001 – 2009
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Oct 18, 2010 · Synced Sep 23, 2026, 8:54 PM EDT
Active, not recruiting Phase 3 Interventional

Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL

NCT05164341
View directory record Official record
Conditions
Partial Lipodystrophy
Interventions
metreleptin, Placebo
Drug
Lead sponsor
Chiesi Farmaceutici S.p.A.
Industry
Eligibility
12 Years and older
Enrollment
69 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
13
States / cities
Birmingham, Alabama • Sacramento, California • Boca Raton, Florida + 9 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2026 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Results available

Effects of Human Leptin Replacement

NCT00657605
View directory record Official record
Conditions
Obesity, Metabolic Syndrome, Diabetes
Interventions
Recombinant methionyl human leptin
Drug
Lead sponsor
University of Miami
Other
Eligibility
18 Years to 80 Years
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2010
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Feb 12, 2020 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Results available

Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome

NCT00140244
View directory record Official record
Conditions
HAART-induced Lipodystrophy and Metabolic Syndrome
Interventions
r-metHuLeptin, Placebo
Drug
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2011
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 10, 2017 · Synced Sep 23, 2026, 8:54 PM EDT
Completed Phase 2 Interventional Results available

CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy

NCT02654977
View directory record Official record
Conditions
Familial Partial Lipodystrophy, Nonalcoholic Steatohepatitis, NAFLD
Interventions
Metreleptin
Drug
Lead sponsor
University of Michigan
Other
Eligibility
5 Years and older
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Nov 23, 2020 · Synced Sep 23, 2026, 8:54 PM EDT