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Clinical Trials/EUCTR2021-004452-42-NO
EUCTR2021-004452-42-NO
Active, not recruiting
Phase 1

An interventional, multi-center, randomized, double blinded, placebo controlled study to investigate semaglutide add-on treatment for metabolic control in antipsychotic-using patients (STABIL-NOR – study). - STABIL-NOR

Helse Bergen HF0 sites140 target enrollmentOctober 11, 2022
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ConditionsDrug induced weight gain from anti-psychotic drug treatment in patients with schizophrenia. Treatment with semaglutide, a glucagon-like peptide receptor agonist used to treat diabetes and approved in USA and Europe for treating obesity, could be a way to combat weight gain and achieve glycemic and also metabolic control for people with schizophrenia treated with antipsychoti drugs, however patients with serious mental illness is commonly excluded from phase 3 studies.MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Drug induced weight gain from anti-psychotic drug treatment in patients with schizophrenia. Treatment with semaglutide, a glucagon-like peptide receptor agonist used to treat diabetes and approved in USA and Europe for treating obesity, could be a way to combat weight gain and achieve glycemic and also metabolic control for people with schizophrenia treated with antipsychoti drugs, however patients with serious mental illness is commonly excluded from phase 3 studies.
Sponsor
Helse Bergen HF
Enrollment
140
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 11, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Informed consent obtained before any trial\-related activities. Trial\-related activities are any procedures that are carried out as part of the trial, also including activities to determine suitability for the trial as for example the screening for eligibility.
  • •2\. Men or woman aged between 18 and 70 years, both years included, at the time of signing informed consent.
  • •3\. BMI \= 30 kg/m2 or \= 27 kg/m2 with the presence of prediabetes determined with either fasting plasma glucose (FPG) between 5\.6 and 6\.9 mmol/l and/or HbA1c between 39\-47 mmol/mol measured on two occasions at least 24 hours apart.
  • •These measures will be done at the V1 and the V2 visit, or alternatively a measurement of FPG or HbA1c within the borders of prediabetes performed in the regular clinical treatment during last 2 weeks before screening can be used as the first of the two occasions.
  • •4\. A diagnosis within the schizophrenia\-spectrum according to International classification of diseases version \- 10 (ICD\-10\): F 20, F 22, F 23, F 25, F 28, F 29\.
  • •5\.AP drug use for at least 3 weeks prior to starting study medication and a treatment plan/recommendation for further AP drug use for at least the next 6 months. Antipsychotic drug discontinuation during the trial will not result in exclusion from further participation in the study.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 100

Exclusion Criteria

  • •1\. With relation to glycemic regulation:
  • •a. Type 1 or Type 2 diabetes present or in history.
  • •b. HbA1c \>48 mmol/mol.
  • •c. Latent autoimmune diabetes in adults (LADA).
  • •d. Treatment with a GLP\-1 receptor agonist last 6 months before screening.
  • •e. Treatment with insulin or other glucose\-lowering drug(s) last 3 months before screening.
  • •2\. Thyreoid stimulating hormone (TSH) within the normal range\-Haukeland university hospital: 11\-19 years: 0,51\-4,30 mIU/L, \>20 years: 0,40\-4,50 mIU/L.
  • •3\. Medical or surgical treatment to reduce weight last 6 months before screening, or planned surgical treatment to reduce weight.
  • •4\. Safety criteria:
  • •a. A personal or family history of medullary thyreoid cancer or multippel endokrin neoplasi 2 (MEN 2\).

Outcomes

Primary Outcomes

Not specified

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