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)

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

Further information

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

Laufende Studien (Rekrutierung abgeschlossen)

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
 

Long Term Extension Trial of Setmelanotide (RM-493) for Patients who have completed a trial of Setmelanotide for the treatment of obesity associated with genetic defects upstream of the MC4 Receptor in the Leptin-melanocortin Pathway
Further information
 

A Phase 2, Two-Stage (Open-Label Run-in Followed by Randomized Withdrawal), Double-Blind, Placebo-Controlled Study of Setmelanotide in Patients with Specific Gene Variants in the Melanocortin-4 Receptor Pathway
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 (rekrutierend)

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

  • Diabetes and Social Jet Lag

  •  BMBF – JA Studie

  • Ulmer Kinderstudie

  • Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES)    

Studien in Vorbereitung (2024/2025)

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
 

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)

Efficacy of Semaglutide s.c. once-weekly on Weight Loss and Management in Adolescents with Monogenic Obesity in Clinical Practice

Weight maintenance in adolescents with obesity; long-term treatment with semaglutide 2.4mg s.c. once-weekly.

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.

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.

Medizinprodukte-Studie für Kinder mit Diabetes.