mecasermin: Clinical Trials

26 trials of mecasermin, newest first

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16 completed, 8 terminated, 1 recruiting, 1 withdrawn. 13 Phase 2, 8 Phase 1, 7 Phase 3, 4 Not applicable.

By phase and status

PhaseTrialsStatus
Phase 213Completed 9, Terminated 4
Phase 18Completed 5, Terminated 3
Phase 37Completed 5, Terminated 2
Not applicable4Completed 3, Withdrawn 1

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

TrialPhaseStatusSponsorEnrollmentStartUpdated
IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency
Increlex - Short Stature
Phase 1 / Phase 2CompletedChildren's Hospital Medical Center, Cincinnati72015-12-212024-02-28
A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder
IGF-1, Placebo/saline - Autism Spectrum Disorder
Phase 2TerminatedIcahn School of Medicine at Mount Sinai32014-05-012024-02-08
Treatment of Rett Syndrome With Recombinant Human IGF-1
Recombinant Human Insulin Growth Factor 1 (rhIGF-1), Placebo - Rett Syndrome
Phase 2CompletedBoston Children's Hospital302013-01-012018-03-26
Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome)
Insulin-Like Growth Factor-1 (IGF-1), Normal saline - 22q13 Deletion Syndrome, Phelan-McDermid Syndrome
Phase 2CompletedIcahn School of Medicine at Mount Sinai192012-02-012022-05-12
Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack
mecasermin, 0.9% sodium chloride injection - Heart Failure, Myocardial Infarction
Phase 1 / Phase 2CompletedUniversity College Cork472011-10-012017-03-30
IGF-1 and Bone Loss in Women With Anorexia Nervosa
rhIGF-1, Risedronate, Placebo - Anorexia Nervosa, Osteopenia
Not applicableCompletedMassachusetts General Hospital1482011-10-012020-07-17
IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients
mecasermin, Saline - Ehlers-Danlos Syndrome, Classic
Not applicableCompletedBispebjerg Hospital152011-09-012012-11-20
Effects of IGF-I in HIV Metabolic Disease
mecasermin, Placebo control - HIV Lipodystrophy
Phase 1TerminatedUniversity of Texas Southwestern Medical Center162011-06-012016-03-23
Increlex Treatment of Children With Chronic Liver Disease and Short Stature
Increlex - Growth Failure, Chronic Liver Disease
Not applicableWithdrawnUniversity of California, Los Angeles2011-06-012026-04-14
IGF-I Induced Muscle Glucose Uptake and Interstitial IGF-I Concentrations
Increlex, 0.9% Saline - Type 1 Diabetes Mellitus
Not applicableCompletedPeter Bang82011-04-012012-04-30
Effects of Anorexia Nervosa on Peak Bone Mass
RhIGF-1 with transdermal 17-beta estradiol, Placebo and transdermal 17-beta estradiol - Anorexia Nervosa
Phase 3CompletedMassachusetts General Hospital752011-02-012021-07-13
Treatment of Rett Syndrome With rhIGF-1 (Mecasermin [rDNA]Injection)
rhIGF-1 - Rett Syndrome
Phase 1CompletedBoston Children's Hospital122010-12-012017-06-22
Safety and Efficacy Study of IGF-1 in Duchenne Muscular Dystrophy
IGF-1 - Duchenne Muscular Dystrophy
Phase 1 / Phase 2CompletedChildren's Hospital Medical Center, Cincinnati442010-11-012021-01-20
Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT)
NutropinAq (GH) and Increlex (IGF-I), NutropinAq and placebo - Diabetes
Phase 3CompletedKarolinska University Hospital142009-10-012015-04-07
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
Increlex® - IGF1 Deficiency
RecruitingEsteve Pharmaceuticals, S.A.5002008-12-092026-02-06
Effect of Increlex® on Children With Crohn Disease
rhIGF (Increlex) - Crohn Disease
Phase 2 / Phase 3TerminatedNationwide Children's Hospital32008-10-012018-03-02
IGF-1 Therapy in Patients With Cystic Fibrosis
recombinant human IGF-1, Placebo - Cystic Fibrosis
Phase 1TerminatedStony Brook University152008-06-012013-01-28
rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency
NutropinAq® (Somatropin [rDNA origin]), Increlex® (Mecasermin [rDNA origin] injection) + NutropinAq® (Somatropin [rDNA origin]) - Insulin-like Growth Factor-1 Deficiency
Phase 2TerminatedIpsen1062007-12-012023-03-30
Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency: Phase 2 Study of Insulin-Like Growth Factor-1
Increlex - Growth Failure, X-linked Severe Combined Immunodeficiency (XSCID)
Phase 1 / Phase 2TerminatedNational Institute of Allergy and Infectious Diseases (NIAID)62007-06-012015-07-03
Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents
RhIGF-1 - Anorexia Nervosa
Phase 1 / Phase 2CompletedMassachusetts General Hospital162007-03-012021-11-18

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Conditions studied

Anorexia Nervosa (3)  ·  Dwarfism (3)  ·  Growth Disorders (3)  ·  Autism Spectrum Disorder (2)  ·  Failure to Thrive (2)  ·  Insulin-Like Growth Factor I Deficiency (2)  ·  Rett Syndrome (2)  ·  Autistic Disorder (1)  ·  Body Weight (1)  ·  Bone Diseases, Metabolic (1)  ·  Collagen Diseases (1)  ·  Crohn Disease (1)  ·  Cystic Fibrosis (1)  ·  Diabetes Mellitus (1)  ·  Diabetes Mellitus, Type 1 (1)

Sponsors

Ipsen (6)  ·  Massachusetts General Hospital (3)  ·  Boston Children's Hospital (2)  ·  Children's Hospital Medical Center, Cincinnati (2)  ·  Icahn School of Medicine at Mount Sinai (2)  ·  Bispebjerg Hospital (1)  ·  Esteve Pharmaceuticals, S.A. (1)  ·  Karolinska University Hospital (1)  ·  National Institute of Allergy and Infectious Diseases (NIAID) (1)  ·  National Institute of Neurological Disorders and Stroke (NINDS) (1)  ·  Nationwide Children's Hospital (1)  ·  Peter Bang (1)  ·  Stony Brook University (1)  ·  University College Cork (1)  ·  University of California, Los Angeles (1)

Countries

United States (19)  ·  Sweden (3)  ·  France (2)  ·  Austria (1)  ·  Denmark (1)  ·  French Guiana (1)  ·  Germany (1)  ·  Ireland (1)  ·  Italy (1)  ·  Martinique (1)  ·  Netherlands (1)  ·  Poland (1)  ·  Spain (1)  ·  United Kingdom (1)

Top investigators

Alexander Kolevzon, MD (2)  ·  Mustafa Sahin, MD, PhD (2)  ·  Anne Klibanski, MD (1)  ·  Charlotte Hoeybye, MD (1)  ·  Dana S. Hardin, MD (1)  ·  Erinne Meenaghan, NP (1)  ·  Gajanathan Muthuvel, MD (1)  ·  Karen Miller, MD (1)  ·  Madhu Misra (1)  ·  Madhusmita Misra, MD, MPH (1)  ·  Meilan Rutter, MD (1)

Results publications

PMID 17192294, PMID 25685306, PMID 29029190, PMID 33434161, PMID 35250870, PMID 35395866, PMID 36646053, PMID 37579214, PMID 37811711, PMID 40351246, PMID 40626687

NIH funding

2019 (4), R34MH100276 (1)