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ClinicalTrials.gov public records Last synced Oct 21, 2026, 7:11 AM EDT

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Showing 1–24 of 35 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: r-metHuLeptin Clear all
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 27, 2024 · Synced Oct 21, 2026, 7:11 AM 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 24, 2020 · Synced Oct 21, 2026, 7:11 AM EDT
Completed Phase 2 Interventional Results available

Short-term Effects of Leptin in People With Lipodystrophy

NCT01778556
View directory record Official record
Conditions
Lipodystrophy
Interventions
Metreleptin
Biological
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
14 Years to 70 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Nov 13, 2019 · Synced Oct 21, 2026, 7:11 AM EDT
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 18, 2026 · Synced Oct 21, 2026, 7:11 AM 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 14, 2017 · Synced Oct 21, 2026, 7:11 AM 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 27, 2016 · Synced Oct 21, 2026, 7:11 AM EDT
Completed Phase 2 Interventional Results available

Effects of Leptin Replacement in Children

NCT00659828
View directory record Official record
Conditions
Obesity, Metabolic Syndrome, Diabetes
Interventions
Recombinant methionyl human leptin
Drug
Lead sponsor
University of Miami
Other
Eligibility
5 Years to 18 Years · Male only
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2010
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Feb 13, 2020 · Synced Oct 21, 2026, 7:11 AM 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 15, 2026 · Synced Oct 21, 2026, 7:11 AM 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 16, 2026 · Synced Oct 21, 2026, 7:11 AM EDT
Active, not recruiting Phase 3 Interventional

Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy

NCT02262832
View directory record Official record
Conditions
Lipodystrophy, Diabetes, Hyperlipidemia
Interventions
Metreleptin
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
6 Months to 98 Years
Enrollment
24 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 22, 2026 · Synced Oct 21, 2026, 7:11 AM 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 14, 2015 · Synced Oct 21, 2026, 7:11 AM EDT
Not listed Not applicable Interventional Accepts healthy volunteers

A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide

NCT00691158
View directory record Official record
Conditions
Obesity
Interventions
Pramlintide (Amylin), Placebo (Normal Saline), 2 Metreleptin, Leptin plus Pramlintide
Drug
Lead sponsor
Oregon Health and Science University
Other
Eligibility
18 Years to 45 Years
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2006 – 2024
U.S. locations
1
States / cities
Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Dec 16, 2022 · Synced Oct 21, 2026, 7:11 AM 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 19, 2010 · Synced Oct 21, 2026, 7:11 AM EDT
Completed Phase 3 Interventional

A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)

NCT06548100
View directory record Official record
Conditions
Generalized Lipodystrophy
Interventions
mibavademab
Drug
Lead sponsor
Regeneron Pharmaceuticals
Industry
Eligibility
2 Years and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
2
States / cities
Bethesda, Maryland • Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Oct 21, 2026, 7:11 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Effect of Metreleptin Therapy in the Treatment of Severe Insulin Resistance

NCT00085982
View directory record Official record
Conditions
Severe Insulin Resistance
Interventions
Metreleptin
Drug
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Eligibility
5 Years and older
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2030
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jan 30, 2025 · Synced Oct 21, 2026, 7:11 AM EDT
Terminated Phase 2 Interventional Results available

A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects

NCT01235741
View directory record Official record
Conditions
Obesity
Interventions
Pramlintide+Metreleptin, Placebo
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 65 Years
Enrollment
213 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011
U.S. locations
18
States / cities
Greenbrae, California • La Jolla, California • Denver, Colorado + 15 more
Source: ClinicalTrials.gov public record
Updated Apr 15, 2015 · Synced Oct 21, 2026, 7:11 AM 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 28, 2019 · Synced Oct 21, 2026, 7:11 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Trial of Leptin Administration After Roux-en-Y Gastric Bypass

NCT00710814
View directory record Official record
Conditions
Overweight
Interventions
Leptin, Placebo
Drug · Other
Lead sponsor
Columbia University
Other
Eligibility
25 Years to 65 Years · Female only
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2014
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Nov 16, 2015 · Synced Oct 21, 2026, 7:11 AM 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 2, 2018 · Synced Oct 21, 2026, 7:11 AM 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 13, 2020 · Synced Oct 21, 2026, 7:11 AM 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 15, 2015 · Synced Oct 21, 2026, 7:11 AM 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 30, 2021 · Synced Oct 21, 2026, 7:11 AM 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 11, 2017 · Synced Oct 21, 2026, 7:11 AM 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 7, 2017 · Synced Oct 21, 2026, 7:11 AM EDT