Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity

NCT05333003 | Recruiting

• 1 other identifier: 139/2020
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Rates of obesity in patients with schizophrenia-spectrum disorder (SSD)s have reached epidemic proportions, with established contributing effects of antipsychotic (AP) medications. Among agents approved for chronic weight management, glucagon-like peptide-1 receptor agonists (GLP-1RA) are associated with reductions in cardiovascular mortality, with recent FDA approval for once weekly semaglutide for this indication. This study will investigate whether semaglutide is effective in reducing body weight in overweight or obese individuals with SSDs who are on APs and do not demonstrate adequate weight loss on metformin (the first line treatment for weight loss in SSDs).

Conditions

Schizophrenia Spectrum Disorders

Keywords

Schizophrenia spectrum disorders; GLP-1 receptor agonists; Weight; Antipsychotics

Outcome Measures

Primary Outcomes (1)

• Weight change

  Percentage change in body weight (kg)

  32 weeks

Secondary Outcomes (17)

• Body Mass Index (BMI)

  32 weeks

• Waist circumference

  32 weeks

• Oral glucose tolerance test

  32 weeks

• Visceral and hepatic adiposity

  32 weeks

• Fasting lipid profile

  32 weeks

Other Outcomes (4)

• Structural MRI

  32 weeks

• Resting state functional MRI (rsfMRI)

  32 weeks

• Arterial spin labeling (ASL)

  32 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

Semaglutide medication will be taken by participants on a weekly schedule, and adherence tracked

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Placebo will be taken by participants on a weekly schedule, and adherence tracked

Other: Placebo

Interventions

Semaglutide DRUG

The semaglutide dose will start with 0.25 mg/week, and slowly increased every four weeks as tolerated up to a maximal dose of 2 mg/week

Semaglutide

Placebo OTHER

Placebo will be provided to participants

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable outpatients or inpatients aged 18-70 years, diagnosed with schizophrenia spectrum disorder, or major depressive disorder with psychotic features, or bipolar disorder (does not need to have psychotic features)
• On maintenance treatment with an AP (stable dose for ≥3 months)
• BMI must be ≥30 kg/m2, OR ≥27 kg/m2 with the presence of at least one weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnea, or impaired fasting glucose, OR BMI ≥25 with individual having gained \>5% bodyweight in association with AP treatment
• History of either failure to tolerate metformin or failure to lose ≥5% body weight over at least 16 weeks on the highest tolerated trial of metformin, and who are not currently being treated with metformin (minimum of 1 week metformin-free prior to study entry)

You may not qualify if:

• Liver, or renal dysfunction
• A positive drug urine screen other than cannabis as per PI discretion
• Sexually active females of child-bearing age not on a regular contraceptive, or nursing or with a positive pregnancy test
• Clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, or pulmonary disease
• History of reactive hypoglycaemia
• Treatment within 3 months, or failure to tolerate GLP-1RA
• Type 1 Diabetes (T1D) or current diagnosis of Type 2 Diabetes (T2D), diagnosis of T2D on OGTT screen, or HbA1c \> 6.5%
• Use of Health Canada approved weight-lowering agents, warfarin, coumarin derivatives, or medication with significant renal impact
• Major medical or surgical event within the preceding 3 months
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome
• History of pancreatitis or elevated amylase on screen
• History of severe gastrointestinal disease, (i.e. gastroparesis)
• Acute suicidal risk
• Uncompensated thyroid disorder
• History of heart rhythm disturbances, conduction system abnormalities, or evidence of clinically relevant abnormalities on screening ECG.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

MeSH Terms

Conditions

Body Weight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaret Hahn, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Hahn, MD, PhD

CONTACT

416-535-8501; margaret.hahn@camh.ca

Mahavir Agarwal, MD, PhD

CONTACT

416-535-8501; mahavir.agarwal@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 18, 2022
• Study Start: May 25, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

CA (1)