Clinical studies
In the Paediatric Endocrinology and Diabetology section, we offer a variety of innovative treatment options that are not yet available in routine clinical practice. This means that new treatment options are now available.
Below you will find information about the department's current clinical study activities. These are mainly planned and currently recruiting international, multi-centre therapy studies for patients with (monogenic) obesity, leptin or growth hormone deficiency, or studies for children with type 1 diabetes mellitus.
If you are interested in participating in a study or have questions about current study projects, we will be happy to provide you with information.
Contact
Head of Clinical Studies in the Paediatric Endocrinology and Diabetology Section:
Pauline Kleger, M.Sc.
E-mail: pauline.kleger@uniklinik-ulm.de
Phone: 0731-500-57406
Efficacy and Safety of Tirzepatide Once Weekly versus Placebo for the Treatment of Obesity
and Weight-Related Comorbidities in Adolescents: A Randomised, Double-Blind, Placebo-
Controlled Trial
A Phase 3, Randomised, 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
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 Randomised 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, Randomised, 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
The study is a post-authorisation, 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
Observational study on the treatment of patients with paediatric indications such as growth hormone deficiency (GHD), small for gestational age (SGA), Ullrich-Turner syndrome (UTS) and prepubertal patients with chronic kidney disease (CRI) as well as replacement therapy in adults with pronounced growth hormone deficiency (AGHD) with rh-GH (recombinant human growth hormone) Saizen®.
- ECLip Register
- iDSD and DSD Register
- Register for patients with hypothyroidism
- Register for patients with adrenogenital syndrome (AGS)
- Diabetes patient progress documentation (DPV)
- Structured pre- and aftercare programme after bariatric surgery
- Register for patients with extreme obesity
Diabetes and Social Jet Lag
BMBF - JA Study
Ulm Paediatric Study
Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES)
A 52-week randomized, double-blind, placebo controlled, multi-centre 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.
Medical device study for children with diabetes.