Klinische Studien
In der Sektion Pädiatrische Endokrinologie und Diabetologie bieten wir eine Vielzahl innovativer Behandlungsmöglichkeiten an, die bisher noch nicht in der klinischen Routine verfügbar sind. Damit stehen neue Therapiemöglichkeiten zur Verfügung.
Im Folgenden erhalten Sie Informationen über die aktuellen klinischen Studienaktivitäten der Abteilung. Es handelt sich dabei vor allem um geplante und aktuell rekrutierende internationale, multizentrische Therapiestudien für Patienten mit (monogener) Adipositas, Leptin- oder Wachstumshormonmangel, oder Studien für Kinder mit Diabetes mellitus Typ 1.
Bei Interesse an einer Studienteilnahme oder Fragen zu aktuellen Studienprojekten informieren wir Sie gerne.
Kontakt
Leitung der klinischen Studien in der Sektion Pädiatrische Endokrinologie und Diabetologie:
Pauline Kleger, M.Sc.
E-Mail: pauline.kleger@uniklinik-ulm.de
Telefon: 0731-500-57406
Laufende Studien (in der Rekrutierungsphase)
Open-label, Phase 3b study to evaluate effectiveness, safety and pharmacokinetic parameters of metreleptin in patients under 6 years of age with generalised lipodystrophy and associated diabetes mellitus and/or hypertriglyceridaemia.
Further information: Study Details | Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy | ClinicalTrials.gov
A 24-Month, Multi-Centre, Open Label Phase IV Post Authorisation Efficacy Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in Patients with Partial Lipodystrophy.
A 52-week randomized, double-blind, placebo controlled, multi-center Phase 2b study with a 52-week blinded extension assessing safety and efficacy of frexalimab, a CD40L antagonist
monoclonal antibody, for preservation of pancreatic β-cell function in adults and adolescents with newly diagnosed type 1 diabetes on insulin therapy
Further information: Study Details | FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS) | ClinicalTrials.gov
A Randomized, Double-blind, 2-arm, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Newly Diagnosed Stage 3 Type 1 Diabetes (T1D)
An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Monogenic Obesity Due to Biallelic Loss of Function Variants of the LEP Gene
Further information: Study Details | NCT07220772 | A Study EvaluatingMibavademab Treatment ofObesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults | ClinicalTrials.gov
Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
Further information: Study Details | NCT07302802 | Efficacyof Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With MonogenicObesity in Clinical Practice | ClinicalTrials.gov
Laufende Studien (Rekrutierung abgeschlossen)
Efficacy and Safety of Tirzepatide Once Weekly versus Placebo for the Treatment of Obesity
and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo-
Controlled Trial
Weight maintenance in adolescents with obesity; long-term treatment with semaglutide 2.4mg s.c. once-weekly.
Further information: Study Details | STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss | ClinicalTrials.gov
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial: 5 Independent Sub-studies of Setmelanotide in Patients with POMC, PCSK1, LEPR, SRC1, SH2B1, and PCSK1 N221D Gene Defects in the Melanocortin-4 Receptor Pathway
Further information
An interventional, randomised, double-blind, parallel group, placebo-controlled, multi-national clinical study period.
Long-term safety and efficacy of semaglutide s.c. once-weekly on weight management in children and adolescents (aged 6 to <18 years) with obesity or overweight
Further information
A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients with Acquired Hypothalamic Obesity
A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency
Further information
Qualitätssicherungs-/Unbedenklichkeitsstudien nach Zulassung
The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin.
Further information
A Registry of Patients with Biallelic Pro-Opiomelanocortin (POMC), Proprotein Convertase Subtilisin/Kexin Type 1 (PCSK1), or Leptin Receptor (LEPR) Deficiency Obesity, or Bardet-Biedl Syndrome (BBS), Treated with Setmelanotide
Anwendungsbeobachtung zur Therapie von Patienten mit pädiatrischen Indikationen wie Wachstumshormon-Mangel (GHD), Small for Gestational Age (SGA), Ullrich-Turner-Syndrom (UTS) und von präpubertären Patienten mit chronischer Nierenerkrankung (CRI) sowie Substitutionstherapie bei Erwachsenen mit ausgeprägtem Wachstumshormonmangel (AGHD) mit rh-GH (rekombinantes humanes Wachstumshormon) Saizen®
Beobachtungsstudien / Registerstudien
- ECLip Register
- iDSD und DSD Register
- Register für PatientInnen mit Hypothyreose
- Register für PatientInnen mit Adrenogenitales Syndrom (AGS)
- Diabetes-Patienten-Verlaufsdokumentation (DPV)
- Strukturiertes Vor- und Nachsorgeprogramm nach Bariatrischer Chirurgie
- Register für Patienten mit extremer Adipositas
- iGO Register: Register für Patienten mit monogener Adipositas
- FeProCAYA: Fertilitätsprotektion für Kinder und Jugendliche in der pädiatrischen Onkologie
Diabetes and Social Jet Lag
BMBF – JA Studie
Ulmer Kinderstudie
Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES)
Studien in Vorbereitung (2026)
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed with Type 1 Diabetes Aged ≥1 to <36 Years
