Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
104
Countries
1
Sites
1
Schizophrenia
The objective of this study is to investigate long term (26 weeks) effects of semaglutide once-weekly vs. semaglutide placebo once-weekly on the metabolic state in prediabetic or diabetic patients with schizophrenia, aged 18 years to 65 years, who have initiated treatment with clozapine or olanzapine.
Key facts
- Sponsor
- Psykiatrisk Center Kobenhavn
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- completed 25 Feb 2026
- Decision date (initial)
- 2024-11-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordisk A/S
External identifiers
- EU CT number
- 2024-518746-24-00
- EudraCT number
- 2020-000102-28
- WHO UTN
- U1111-1232-3637
- ClinicalTrials.gov
- NCT04892199
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety
The objective of this study is to investigate long term (26 weeks) effects of semaglutide once-weekly vs. semaglutide placebo once-weekly on the metabolic state in prediabetic or diabetic patients with schizophrenia, aged 18 years to 65 years, who have initiated treatment with clozapine or olanzapine.
Conditions and MedDRA coding
Schizophrenia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10039628 | Schizophrenia and other psychotic disorders | 10037175 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | From trial start until all data have been analysed Semaglutide- and placebopens have been provided by Novo Nordisk A/S.
|
Randomised Controlled | Double | [{"id":89461,"code":5,"name":"Carer"},{"id":89460,"code":1,"name":"Subject"},{"id":89462,"code":3,"name":"Monitor"},{"id":89459,"code":2,"name":"Investigator"},{"id":89458,"code":4,"name":"Analyst"}] | Semaglutide: Semaglutide 1.34 mg/ml, 1.5 ml pre-filled pen-injector is supplied in pens for injection containing 2.0 mg of the GLP-1RA semaglutide in 1.5 ml sterile water with disodiumphosphate and propylenglycol, and phenol for conservation (pH 8.15). Directions for use will be given together with trial products. The possible doses of semaglutide are 0.25 mg, 0.50 mg and 1.0 mg. The initial weekly dose will be 0.25 mg for four weeks, then 0.5 mg for four weeks and then 1.0 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.0 mg semaglutide will remain on 0.5 mg once-weekly. The injection is administered subcutaneously once-weekly. Placebo: The semaglutide placebo pens contain “XX-vehicle” (no active drug) and are administered in the same way and volume as semaglutide. The semaglutide placebo is specially packed for this study and will be used in the study only. The initial weekly dose will be 0.25 mg for four weeks, then 0.5 mg for four weeks and then 1.0 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.0 mg semaglutide placebo will remain on 0.5 mg once-weekly. The injection is administered once-weekly. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Initiated current daily treatment with clozapine or olanzapine, respectively, within 60 months & Diagnosed with prediabetes or type 2 diabetes, with the following plasma levels: Prediabetes: HbA1c 35-47 mmol/mol or fasting plasma glucose (FPG) 5.6-6.9 mM or 2-h during 75 mg OGGT 7.8-11.0 mM. The test result has to be confirmed on a different day. Type 2 diabetes: HbA1c 48-57 mmol/mol or fasting plasma glucose (FPG) 6.9-9.9 mM or 2h OGTT > 11 mM (although FPG and HbA1c might still be under the diagnostic range). The test result has to be confirmed on a different day.
Exclusion criteria 1
- Suicidal behavior and/or plasma HbA1c > 57 mmol/mol (tested twice) in which case the patient will be excluded from the study and transferred to general practitioner or hospital for diabetic treatment & no diabetic medication is allowed except for the trial medicine.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c)
Secondary endpoints 1
- Changes in body weight, hip, waist circumference, blood pressure, heart rate, plasma insulin, C-peptide, glucagon, incretin hormones, lipid profile, proteomics and bone markers, insulin sensitivity, beta-cell function (evaluated by HOMA. Body composition and bone density evaluated by DXA-scan), liver function (transaminases), liver fibrosis (fibrosis-4 (FIB-4) score), alcohol, tobacco and drug use, preference for sweet and fatty candy, psychopathology, activity and quality of life.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ozempic 1 mg solution for injection in pre-filled pen
PRD6392564 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1.0 mg/ml milligram(s)/millilitre
- Max total dose
- 1.0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 26 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/005
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo for semaglutide, CompCart 1.5 ml, PDS290
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Psykiatrisk Center Kobenhavn
- Sponsor organisation
- Psykiatrisk Center Kobenhavn
- Address
- Edel Sauntes Alle 10
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Psykiatrisk Center Kobenhavn
- Contact name
- Anders Fink-Jensen
Public contact point
- Organisation
- Psykiatrisk Center Kobenhavn
- Contact name
- Mette Kruse Klausen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 104 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Psykiatrisk Center Kobenhavn
Psykiatrisk Centre København, Edel Sauntes Alle 10, 2100, Copenhagen Oe
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Results SUM-135146
|
2026-05-21T10:56:52 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay-person summary | 2026-05-21T10:57:00 | Submitted | Laypersons Summary of Results |
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay-person summary | 1 |
| Protocol (for publication) | Protocol Sema-Psychiatry | 12.0 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation_SemaPsychiatry_Del 1 | 11.0 |
| Subject information and informed consent form (for publication) | Deltagerinformation_SemaPsychiatry_Del 2 | 11.0 |
| Subject information and informed consent form (for publication) | Samtykkeerklring_SemaPsychiatry | 11.0 |
| Subject information and informed consent form (for publication) | Samtykkeerklring_SemaPsychiatry_Fremtidig forskning | 11.0 |
| Summary of results (for publication) | Published paper including results | 1 |
| Summary of results (for publication) | Supplementary results | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-09 | Denmark | Acceptable 2024-10-31
|
2024-11-04 |