metreleptin: Clinical Trials

31 trials of metreleptin, newest first

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18 completed, 5 active not recruiting, 4 recruiting, 3 terminated. 19 Phase 2, 4 Phase 3, 3 Phase 1, 2 Not applicable, 2 Phase 4.

By phase and status

PhaseTrialsStatus
Phase 219Completed 15, Active not recruiting 3, Recruiting 1
Phase 34Active not recruiting 2, Recruiting 1, Terminated 1
Phase 13Completed 2, Terminated 1
Not applicable2Completed 1, Terminated 1
Phase 42Completed 1, Recruiting 1

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Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy
Metreleptin - Generalized Lipodystrophy
Phase 3TerminatedAmryt Pharma12025-05-232026-07-22
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Metreleptin - Familial Partial Lipodystrophy
Phase 3RecruitingChiesi Farmaceutici S.p.A.242024-10-142026-07-16
Metreleptin in Anorexia Nervosa
Metreleptin, Sodium chloride - Anorexia Nervosa
Phase 2RecruitingGabriella Milos502024-05-312026-07-29
Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Metreleptin - Partial Lipodystrophy
Phase 4RecruitingAmryt Pharma122024-02-082025-07-03
Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL)
Metreleptin - Lipomatosis, Multiple Symmetrical
Phase 2Active not recruitingUniversity of Michigan42023-08-012025-06-12
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
metreleptin, Placebo - Partial Lipodystrophy
Phase 3Active not recruitingChiesi Farmaceutici S.p.A.692021-12-172026-06-15
The Effects of Metreleptin in Congenital Leptin Deficiency
Metreleptin - Congenital Leptin Deficiency (Disorder)
CompletedNorthwestern University22019-06-202021-12-30
Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
Metreleptin - Generalized Lipodystrophy
Phase 4CompletedAegerion Pharmaceuticals, Inc.112018-11-142025-11-26
MEASuRE: Metreleptin Effectiveness And Safety Registry
Metreleptin - Generalised Lipodystrophy, Partial Lipodystrophy
RecruitingChiesi Farmaceutici S.p.A.1002016-10-112026-07-16
CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy
Metreleptin - Familial Partial Lipodystrophy, Nonalcoholic Steatohepatitis
Phase 2CompletedUniversity of Michigan112015-09-292020-11-24
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Metreleptin - Diabetes, Lipodystrophy
Phase 2Active not recruitingNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)292014-10-142026-10-19
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Metreleptin - Lipodystrophy, Diabetes
Phase 3Active not recruitingNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)242014-10-092026-09-22
Short-term Effects of Leptin in People With Lipodystrophy
Metreleptin - Lipodystrophy
Phase 2CompletedNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)252013-01-262019-11-13
Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy
Metreleptin - Fatty Liver Disease, Nonalcoholic, Nonalcoholic Steatohepatitis
Phase 2CompletedUniversity of Michigan232012-10-082017-06-14
Effects of Metreleptin in Type 1 Diabetes Mellitus
Leptin - Type 1 Diabetes
Phase 1TerminatedUniversity of Texas Southwestern Medical Center82010-09-012019-08-28
Study of Leptin for the Treatment of Hypothalamic Amenorrhea
r-metHuLeptin, Oral Contraceptive Pills (OCPs), Placebo - Amenorrhea
Phase 2CompletedBeth Israel Deaconess Medical Center202010-04-012017-05-17
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
Placebo, Pramlintide and Metreleptin - Obesity
Phase 2CompletedAstraZeneca2742008-11-012015-04-15
Leptin in the Maintenance of Reduced Body Weight
Leptin, Placebo - Obesity
Phase 2CompletedBeth Israel Deaconess Medical Center242008-07-012017-04-07
Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
pramlintide acetate, metreleptin, placebo-P - Overweight, Obesity
Phase 2CompletedAstraZeneca6362008-04-012015-04-15
Trial of Leptin Administration After Roux-en-Y Gastric Bypass
Leptin, Placebo - Overweight
Phase 1 / Phase 2CompletedColumbia University312008-04-012015-11-16

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Conditions studied

Lipodystrophy (9)  ·  Diabetes Mellitus (8)  ·  Obesity (8)  ·  Hypertriglyceridemia (6)  ·  Lipodystrophy, Congenital Generalized (3)  ·  Lipodystrophy, Partial, Acquired (3)  ·  Non-alcoholic Fatty Liver Disease (3)  ·  Overweight (3)  ·  Hyperlipidemias (2)  ·  Insulin Resistance (2)  ·  Lipodystrophy, Familial Partial (2)  ·  Metabolic Syndrome (2)  ·  Amenorrhea (1)  ·  Anorexia Nervosa (1)  ·  Depression (1)

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (5)  ·  AstraZeneca (3)  ·  Beth Israel Deaconess Medical Center (3)  ·  Chiesi Farmaceutici S.p.A. (3)  ·  University of Michigan (3)  ·  Amryt Pharma (2)  ·  Columbia University (2)  ·  University of Miami (2)  ·  University of Texas Southwestern Medical Center (2)  ·  Aegerion Pharmaceuticals, Inc. (1)  ·  Baylor College of Medicine (1)  ·  Bristol-Myers Squibb (1)  ·  Elif Oral (1)  ·  Gabriella Milos (1)  ·  Northwestern University (1)

Countries

United States (27)  ·  France (3)  ·  Germany (3)  ·  Italy (3)  ·  Belgium (2)  ·  United Kingdom (2)  ·  Brazil (1)  ·  Canada (1)  ·  Chile (1)  ·  Israel (1)  ·  Netherlands (1)  ·  Poland (1)  ·  Spain (1)  ·  Switzerland (1)

Top investigators

Rebecca J Brown, M.D. (4)  ·  Abhimanyu Garg, M.D. (2)  ·  Elif A Oral, MD (2)  ·  Julio Licinio, MD (2)  ·  Ashok Balasubramanyam, MD (1)  ·  Christos S Mantzoros, MD (1)  ·  Christos S Mantzoros, MD, DSc (1)  ·  Christos S Mantzoros, MD, ScD (1)  ·  Elif A Oral, MD, MS (1)  ·  Elif Oral (1)  ·  Janet Boylan (1)  ·  Jean Chan, MD (1)  ·  Judith Korner, MD,PhD (1)  ·  Lisa Neff, MD (1)

Results publications

PMID 26589105, PMID 28324110, PMID 34677608, PMID 31194872, PMID 19889232, PMID 21070531, PMID 33051459, PMID 34223895, PMID 35291351, PMID 37595266, PMID 39097160, PMID 10523015, PMID 11443202, PMID 15070752, PMID 15713712, PMID 15949871, PMID 17517446, PMID 17684509, PMID 17986612, PMID 18726828, PMID 18769731, PMID 18854428, PMID 19727665, PMID 20101893, PMID 21464293, PMID 21593494, PMID 21660636, PMID 21741057, PMID 21917874, PMID 22068254, PMID 22542724, PMID 22965160, PMID 23193213, PMID 23382191, PMID 23439261, PMID 23969187, PMID 24703486, PMID 24926953, PMID 25070319, PMID 25148234, PMID 25540981, PMID 25734254, PMID 26900642, PMID 27642538, PMID 29723161, PMID 29920214, PMID 32191645, PMID 32573497, PMID 33045195, PMID 33890058

NIH funding

M01RR001032 (2), R01DK058785 (1), R01DK058851 (1), R01DK064773 (1), R01DK079929 (1), R01DK088114 (1), R03DK074488 (1), R21DK081050 (1), R34HD048526 (1), UL1RR024156 (1)