Metabolic DisturbancePhase 4NCT04892199

Does GLP-1RA Prevent Deterioration of Metabolic State in Prediabetic and Diabetic Patients Treated With Antipsychotic Medication?

A Phase 4 study testing Semaglutide, 1.34 mg/mL in people with Metabolic Disturbance and Schizophrenia, run by Anders Fink-Jensen, MD, DMSci at 3 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Background and objective: Clozapine and olanzapine are some of the most effective antipsychotic drugs, but unfortunately, both drugs induce weight gain and conveys a high degree of metabolic disturbances. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Metabolic Disturbance, Schizophrenia, Type 2 Diabetes
What is being tested?: Semaglutide, 1.34 mg/mL
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: 3 sitesDenmark
Study dates: 1 Sep 2021to 1 Aug 2026
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed oral and written consent
Diagnosed with schizophrenia according to the criteria of ICD-10 (International Classification of Diseases, World Health Organization (WHO)) or the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, the American Psychiatric Association)
Initiating current treatment with clozapine or olanzapine within 60 months (not PRN ordinations)
Age 18 years to 65 years (both included)
Body mass index (BMI) ≥25 kg/m2
Diagnosed with prediabetes or type 2 diabetes, after initiation of current treatment with clozapine- or olanzapine, 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.

Who cannot join

Acute worsening of psychosis based on a clinical evaluation (score of 6 or 7 on the CGI-S scale)
Coercive measures
Females of child-bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant.
Women who are not willing to use adequate contraceptive during the full length of the study
Patients treated with corticosteroids or other hormone therapy (except oestrogens)
Any active substance abuse or dependence for the past six months (except for nicotine)

Show all 18Show fewer

Impaired hepatic function (plasma liver transaminases >3 times upper normal limit)
Impaired renal function (serum creatinine >150 μmol/l and/or macroalbuminuria)
Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times upper normal limit)
Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg
Any condition that the investigator feels would interfere with trial participation
Receiving any experimental or pre-marketing drug within the last 3 months
Use of weight-lowering pharmacotherapy within the preceding 3 month
Known type 1 diabetes
Suicidal behavior as judged by the investigator and based on clinical evaluation. At all contact with patient attendance possible suicidality will be evaluated according to the guidelines. If the patient is evaluated as suicidal, the person will be excluded from the study and evaluated by a senior consultant in psychiatry, who will take further action.
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 medicin.
Any known contraindication towards the treatment with semaglutide.

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

Psychosis Research Unit, Aarhus University Hospital, Psychiatry,
Aarhus, 8200
Psychiatric Centre Copenhagen, Rigshospitalet
Copenhagen, 2100
Psychiatric Centre Nordsjaelland, Hillerød
Hillerød, 3400

Other trials in Denmark

About this study

Official title: Does the Glucagon-like Peptide-1 Receptor Agonist Semaglutide Prevent Deterioration of Metabolic State in Prediabetic or Diabetic Patients With Schizophrenia Treated With the Antipsychotic Compounds Clozapine or Olanzapine?

Background and objective:

Clozapine and olanzapine are some of the most effective antipsychotic drugs, but unfortunately, both drugs induce weight gain and conveys a high degree of metabolic disturbances. The antipsychotic-induced side-effects cause a major clinical problem among patients diagnosed with schizophrenia receiving antipsychotic treatment. Limited effects have been demonstrated for counteracting the side-effects by the switch of antipsychotic therapy, non-pharmacological/behavioural interventions or adjunct pharmacological treatments. Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA,) is approved for the treatment of type 2 diabetes worldwide. The objective of the study is to investigate effects of semaglutide once-weekly vs. semaglutide placebo once-weekly on the metabolic state in prediabetic or diabetic patients with schizophrenia, who have initiated treatment with clozapine or olanzapine.

Methods and analysis:

Trial design, intervention and participants: The study is a 26-week, double-blinded, randomized, parallel-group, placebo-controlled, good clinical practice (GCP)-monitored, clinical trial. 104 prediabetic or diabetic patients diagnosed with a schizophrenia, age 18 years and 65 years, who have initiated of clozapine- or olanzapine-treatment within 5 years will be included in the study. The patients will be randomized to receive blinded treatment in one of the two study arms; semaglutide once-weekly vs. semaglutide placebo. All participants who complete the 26 weeks of intervention, will be invited for a follow up visit 1.5 yeras after study completion.

The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c). Secondary endpoints include change in body weight, hip and waist circumference, vitals, and plasma levels of insulin, glucose, C-peptid, insulin sensitivity, beta cell function, glucagon, liver function, lipid profile, incretin hormones, lipid profile, bone makers, body composition, bone density and proteomic analyses. Additional endpoints include alcohol, tobacco and drug use, food preferences, psychopathology, activity and quality of life.

Conditions: Metabolic Disturbance, Schizophrenia, Type 2 Diabetes, Clozapine, GLP-1, Olanzapine
Being tested: Semaglutide, 1.34 mg/mL, Semaglutide-placebo
Medical subject headings: Schizophrenia, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Semaglutide, 1.34 mg/mLDrug
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). Direction 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.
Semaglutide-placeboDrug
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. If the lowest tolerated dose is less than 0.5 mg of semaglutide placebo once-weekly, the patient will be excluded from the study.

Study groups in NCT04892199
Study group	Role	What they receive
Semaglutide injection once-weekly	Active comparator	Not described Receives: Drug: Semaglutide, 1.34 mg/mL
Semaglutide-Placebo injection once-weekly	Placebo comparator	Not described Receives: Drug: Semaglutide-placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c).
Measured: 26 weeks

Secondary outcomes (24)

Body weight (Kg)
Measured: 26 weeks
Hip and Waist circumference (Cm)
Measured: 26 weeks
Incretin hormones (Blood sampling)
GLP-1, GLP-2 and GIP
Measured: 26 weeks
Bone Markers (Blood sampling)
Calcitonin, Vit-D, Ca, Phosphate, Mg, PTH, PINP, CTX, OC
Measured: 26 weeks
Lipid Profile (Blood sampling)
LDL, HDL, triglycerider, total kolesterol,
Measured: 26 weeks
Hormones (blood sampling)
Insulin, glucagon and C-peptide
Measured: 26 weeks
Visceral fat
DXA scanning
Measured: 26 weeks
Android to Gynoid fat ratio
DXA scanning
Measured: 26 weeks
Total body fat
DXA scanning
Measured: 26 weeks
Bone density
DXA scanning
Measured: 26 weeks
Psychopathology
PANSS-6 interview
Measured: 26 weeks
Registration of body movements/level of activity with a sensor
Activity measurements (approximate for sleep, inactivity, energy expenditure and steps taken by the patient) will be collected continuously by the use of a wearable activity device worn by the patient for 1 week from inclusion day and 1 week at the end of the study
Measured: 26 weeks
Reward value of sweet and fatty candy
Clicker test
Measured: 26 weeks
Alcohol use
Questionnaires: AUDIT
Measured: 26 weeks
Tobacco use
Questionnaires: FNTD
Measured: 26 weeks
Drug use
Questionnaires: DUDIT
Measured: 26 weeks
Schizophrenia quality of life scale
Questionnaire: SQLS
Measured: 26 weeks
Psychosocial disability
Rating GAPD
Measured: 26 weeks
Liver function (blood sampling)
ALT, ALP, AST, trombocytes and bilirubin
Measured: 26 weeks
Proteomic analyses (Blood sampling)
Inflammatory biomarkers and cytokines: IFN-γ, TNF-α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, MDA, plasma antioxidants uric acid and, vitaminC
Measured: 26 weeks
Proteomic analyses (Urine sampling)
biomarkers for measurement of systemic oxidative stress on DNA and RNA: 8-oxo-7,8-dihydro2´-deoxyguanosine (8-oxodG) and 8-oxo-7,8-dihydroguanosine (8-oxoGuo
Measured: 26 weeks
FIB-4 score
A non-invasive scoring system for Liver Fibrosis is a non-invasive scoring system based on several laboratory tests (ALT, AST, trombocytes) and age
Measured: 26 weeks
Vitals
Blood pressure and pulse
Measured: 26 weeks
Insulin sensitivity and beta cell function
evaluated by homeostatic model assessment
Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20211 Aug 2026

First posted19 May 2021
Study start1 Sep 2021
Primary completion1 Mar 2026 (estimated)
Study completion1 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Metabolic DisturbanceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomised, Double-blinded, Parallel, Placebo-controlled, clinical trial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 104 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04892199
Sponsor's protocol ID: SemaPsychiatry
Status last verified: Sep 2024
First submitted: 1 Mar 2021
Last updated: 25 Sep 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

Sass MR, Klausen MK, Schwarz CR, Rasmussen L, Giver MEB, Hviid M, Schilling C, Zamorski A, Jensen A, Gefke M, Storgaard H, Oturai PS, Kjaer A, Hartmann B, Holst JJ, Ekstrom CT, Vinberg M, Correll CU, Vilsboll T, Fink-Jensen A. Semaglutide and Early-Stage Metabolic Abnormalities in Individuals With Schizophrenia Spectrum Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Feb 1;83(2):128-138. doi: 10.1001/jamapsychiatry.2025.3639.
PubMed 41335431
Sass MR, Danielsen AA, Kohler-Forsberg O, Storgaard H, Knop FK, Nielsen MO, Sjodin AM, Mors O, Correll CU, Ekstrom C, Vinberg M, Nielsen J, Vilsboll T, Fink-Jensen A. Effect of the GLP-1 receptor agonist semaglutide on metabolic disturbances in clozapine-treated or olanzapine-treated patients with a schizophrenia spectrum disorder: study protocol of a placebo-controlled, randomised clinical trial (SemaPsychiatry). BMJ Open. 2023 Jan 31;13(1):e068652. doi: 10.1136/bmjopen-2022-068652.
PubMed 36720576

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does the Glucagon-like Peptide-1 Receptor Agonist Semaglutide Prevent Deterioration of Metabolic State in Prediabetic or Diabetic Patients With Schizophrenia Treated With the Antipsychotic Compounds Clozapine or Olanzapine?
ClinicalTrials.gov ID: NCT04892199
Acronym / sponsor ID: SemaPsychiatry
Conditions: Metabolic Disturbance, Schizophrenia, Type 2 Diabetes, Clozapine, GLP-1, Olanzapine
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 104 participants (estimated)
Lead sponsor: Anders Fink-Jensen, MD, DMSciUniversity, hospital or other
Study start: 1 Sep 2021 (actual)
Primary completion: 1 Mar 2026 (estimated)
Study completion: 1 Aug 2026 (estimated)
First posted: 19 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background and objective:

Methods and analysis:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Randomised, Double-blinded, Parallel, Placebo-controlled, clinical trial

Arm	Type	Receives
Semaglutide injection once-weekly	Active comparator	Drug: Semaglutide, 1.34 mg/mL
Semaglutide-Placebo injection once-weekly	Placebo comparator	Drug: Semaglutide-placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Informed oral and written consent
Diagnosed with schizophrenia according to the criteria of ICD-10 (International Classification of Diseases, World Health Organization (WHO)) or the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, the American Psychiatric Association)
Initiating current treatment with clozapine or olanzapine within 60 months (not PRN ordinations)
Age 18 years to 65 years (both included)
Body mass index (BMI) ≥25 kg/m2

Key exclusion criteria (18 listed)

Acute worsening of psychosis based on a clinical evaluation (score of 6 or 7 on the CGI-S scale)
Coercive measures
Females of child-bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant.
Women who are not willing to use adequate contraceptive during the full length of the study
Patients treated with corticosteroids or other hormone therapy (except oestrogens)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Semaglutide, 1.34 mg/mLSemaglutide 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). Direction 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.	Drug	Semaglutide injection once-weekly
Semaglutide-placeboThe 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. If the lowest tolerated dose is less than 0.5 mg of semaglutide placebo once-weekly, the patient will be excluded from the study.	Drug	Semaglutide-Placebo injection once-weekly

Primary outcome

The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c).
Time frame: 26 weeks

24 secondary outcomes

Body weight (Kg)
Time frame: 26 weeks
Hip and Waist circumference (Cm)
Time frame: 26 weeks
Incretin hormones (Blood sampling)
Time frame: 26 weeks
Bone Markers (Blood sampling)
Time frame: 26 weeks
Lipid Profile (Blood sampling)
Time frame: 26 weeks
Hormones (blood sampling)
Time frame: 26 weeks
Visceral fat
Time frame: 26 weeks
Android to Gynoid fat ratio
Time frame: 26 weeks
Total body fat
Time frame: 26 weeks
Bone density
Time frame: 26 weeks
Psychopathology
Time frame: 26 weeks
Registration of body movements/level of activity with a sensor
Time frame: 26 weeks
Reward value of sweet and fatty candy
Time frame: 26 weeks
Alcohol use
Time frame: 26 weeks
Tobacco use
Time frame: 26 weeks
Drug use
Time frame: 26 weeks
Schizophrenia quality of life scale
Time frame: 26 weeks
Psychosocial disability
Time frame: 26 weeks
Liver function (blood sampling)
Time frame: 26 weeks
Proteomic analyses (Blood sampling)
Time frame: 26 weeks
Proteomic analyses (Urine sampling)
Time frame: 26 weeks
FIB-4 score
Time frame: 26 weeks
Vitals
Time frame: 26 weeks
Insulin sensitivity and beta cell function
Time frame: 26 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
Derived from this study: PubMed 41335431Sass MR, Klausen MK, Schwarz CR, Rasmussen L, Giver MEB, Hviid M, Schilling C, Zamorski A, Jensen A, Gefke M, Storgaard H, Oturai PS, Kjaer A, Hartmann B, Holst JJ, Ekstrom CT, Vinberg M, Correll CU, Vilsboll T, Fink-Jensen A. Semaglutide and Early-Stage Metabolic Abnormalities in Individuals With Schizophrenia Spectrum Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Feb 1;83(2):128-138. doi: 10.1001/jamapsychiatry.2025.3639.
Derived from this study: PubMed 36720576Sass MR, Danielsen AA, Kohler-Forsberg O, Storgaard H, Knop FK, Nielsen MO, Sjodin AM, Mors O, Correll CU, Ekstrom C, Vinberg M, Nielsen J, Vilsboll T, Fink-Jensen A. Effect of the GLP-1 receptor agonist semaglutide on metabolic disturbances in clozapine-treated or olanzapine-treated patients with a schizophrenia spectrum disorder: study protocol of a placebo-controlled, randomised clinical trial (SemaPsychiatry). BMJ Open. 2023 Jan 31;13(1):e068652. doi: 10.1136/bmjopen-2022-068652.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anders Fink-Jensen, MD principal investigator

Psychiatric Centre Copenhagen

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Semaglutide, 1.34 mg/mL in people with Metabolic Disturbance and Schizophrenia, run by Anders Fink-Jensen, MD, DMSci at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c). (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04892199, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.