Clinical Studies

In the Division of Paediatric Endocrinology and Diabetology, we offer a variety of innovative treatment options that are not yet available in routine clinical practice. This provides new therapeutic opportunities.
Below, you will find information on the department's current clinical study activities. These are mainly planned and currently recruiting international, multicentre 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 Division of Paediatric Endocrinology and Diabetology:
Pauline Kleger, M.Sc. 
E-mail: pauline.kleger@uniklinik-ulm.de
Telephone: 0731-500-57406

 

Ongoing studies (in the recruitment phase)

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

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

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.

Medical device study for children with diabetes.

A pivotal clinical performance evaluation of the CareSens Air continuous glucose monitoring system in adolescents and children with diabetes mellitus

Further information: DRKS - Deutsches Register Klinischer Studien

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

 

Ongoing studies (recruitment ended)

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
 

Quality assurance/post-authorisation studies (recruiting)

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

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®.

Observational studies / registry studies

  • Diabetes and social jet lag
  •  BMBF - JA Study
  • Ulm Paediatric Study
  • Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES)

Studies in preparation (2025)

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

An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Obesity Associated with Homozygous Loss-of-Function LEP Gene Mutations