Phase 4 Obesity Trial, Recruiting NCT05744479 Sponsor: Centre for Addiction and Mental Health Condition: Obesity
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Phase 4 Obesity Trial, Recruiting

NCT05744479
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 16 to 65 years
  • People who are stable and being seen as outpatients (not currently admitted to hospital)
  • People who have been diagnosed with an intellectual or developmental disability (IDD)
  • People who have been taking an antipsychotic medication at a stable dose for at least 3 months
  • People whose body mass index (BMI) is 30 or above, OR 27 or above with at least one weight-related health condition such as high blood pressure, abnormal cholesterol, sleep apnea, or raised blood sugar, OR 25 or above if body weight has increased by more than 5% while taking an antipsychotic medication
  • Women of childbearing age who are using an accepted form of contraception for the duration of the trial, such as abstaining from sex, using barrier methods (diaphragm with spermicide and/or latex condom), using hormonal contraception (pill, implant, or injection) for at least six months before and throughout the trial, using an intrauterine device (IUD), or whose partner has had a vasectomy at least 3 months before the trial starts

Who may not be able to join:

  • Women who are pregnant, breastfeeding, or who have a positive pregnancy test
  • People with serious, unmanaged heart, hormone, blood, liver, kidney, or lung conditions identified through clinical assessment or blood tests
  • People who have previously tried metformin and found it did not work or caused intolerable side effects
  • People with a history or diagnosis of Type 1 or Type 2 Diabetes, or whose blood sugar test results indicate diabetes (HbA1c above 6.5%)
  • People with a history of metabolic acidosis or lactic acidosis (a build-up of acid in the body)
  • People currently taking any medications intended to reduce body weight
  • People taking medications that have a significant effect on kidney function (confirm with trial site)
  • People who have had a major medical illness or surgery in the 3 months before joining
  • People who are currently considered to be at acute risk of suicide
  • People with a moderate to severe substance use disorder, not including caffeine or nicotine use

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 4165358501

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Centre for Addiction and Mental Health
Registry
ClinicalTrials.gov
Start date
28 February 2023
Est. completion
1 March 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Individual's percentage change in body weight

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov