NCT01825798 (MET) is a Phase 3 clinical trial of Metformin in Overweight, sponsored by Holland Bloorview Kids Rehabilitation Hospital.

Who is sponsoring NCT01825798?

NCT01825798 is sponsored by Holland Bloorview Kids Rehabilitation Hospital.

What drugs are being tested in NCT01825798?

Interventions in NCT01825798: Metformin, Placebo.

What condition does NCT01825798 study?

NCT01825798 studies Overweight, Autism Spectrum Disorder.

Is NCT01825798 still recruiting?

NCT01825798 is currently completed. Last updated 14 July 2025.

Are results published for NCT01825798?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-14 · How we verify

NCT01825798: MET

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)

Completed Phase 3 Results posted Last updated 14 July 2025

What this trial tests

Phase 3 trial testing Metformin in Overweight in 60 participants. Completed in 1 October 2015.

Timeline

1 April 2013

Primary endpoint
1 June 2015

1 October 2015

Quick facts

Lead sponsor	Holland Bloorview Kids Rehabilitation Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 April 2013
Primary completion	1 June 2015
Estimated completion	1 October 2015
Sites	4 locations across United States, Canada

Drugs / interventions tested

Metformin (metformin) — full drug profile →
Placebo

Conditions studied

Overweight — all drugs for Overweight →
Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Who can join

Adults 6 to 17, any sex, with Overweight or Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in Body Mass Index Z-score
Time frame: Baseline, 16 Weeks

Sponsor's own description

The purpose of this study is to determine whether metformin is safe and effective in the treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who are currently taking atypical antipsychotic medication.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Metformin for Treatment of Overweight Induced by Atypical Antipsychotic Medication in Young People With Autism Spectrum Disorder: A Randomized Clinical Trial.
Anagnostou E, Aman MG, Handen BL, Sanders KB, et al · · 2016 · cited 80× · PMID 27556593 · DOI 10.1001/jamapsychiatry.2016.1232
A Randomized, Placebo-Controlled Trial of Metformin for the Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorder: Open-Label Extension.
Handen BL, Anagnostou E, Aman MG, Sanders KB, et al · · 2017 · cited 27× · PMID 28942807 · DOI 10.1016/j.jaac.2017.07.790

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting

Other recruiting trials for Overweight

Currently open trials in the same condition.

NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
NCT07472881 — Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women · NA · recruiting
NCT07465965 — A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults · Phase 1 · recruiting
NCT07407348 — A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the · Phase 1 · recruiting
NCT07400653 — A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) · Phase 3 · recruiting

Other Holland Bloorview Kids Rehabilitation Hospital trials

Trials by the same sponsor.

NCT07360171 — Validity Assessment of Sensors for Movement Tracking With Children/Youth With Diverse Neuromotor Abilities · not yet recruiting
NCT04041713 — A Pilot Study of an Antioxidant Cocktail vs. Placebo in the Treatment of Children and Adolescents With Rett Syndrome · Phase 2 · not yet recruiting
NCT06341127 — Fluoxetine in KCNC1-related Disorder · NA · completed
NCT03710343 — Metformin for Motor and Cognitive Improvement in Children With Cerebral Palsy: A Feasibility Study · Phase 2 · completed
NCT06129058 — Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01825798 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Holland Bloorview Kids Rehabilitation Hospital
Last refreshed: 14 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01825798.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing