Phase 2 Eating Disorders Trial, Recruiting NCT05664516 Sponsor: Massachusetts General Hospital Condition: Eating Disorders
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Phase 2 Eating Disorders Trial, Recruiting

NCT05664516
Recruiting Phase 2

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:

  • You are between 18 and 70 years old (male or female)
  • Your Body Mass Index (BMI) is 18.5 or higher
  • You have been diagnosed with Binge Eating Disorder (BED), a related eating disorder involving binge eating that does not happen as often or for as long as typical BED, or Bulimia Nervosa where weight control after binge eating happens through excessive exercise and/or fasting (confirm with trial site for exact diagnosis requirements)

Who may not be able to join:

  • You have had a substance use disorder (such as alcohol or drug misuse) in the last 6 months, or the study doctor suspects you currently have one
  • You have recently changed a medication and it has not yet fully settled in your system (confirm with trial site)
  • You are taking medication for binge eating disorder or weight loss and have not been on the same dose for at least 12 weeks
  • You have a history of inflammatory bowel disease or an untreated thyroid condition
  • You have epilepsy that is not well controlled, meaning you have had a seizure within the last 12 months
  • You have certain heart conditions, including irregular heartbeats, coronary heart disease, a known long QT interval, or a thickened heart muscle (confirm with trial site)
  • Your red blood cell level (hematocrit) is more than 2% below the normal range
  • Your blood sugar control marker (HbA1c) is above 8%, which may suggest poorly managed diabetes
  • You currently use insulin
  • Your liver enzyme levels (ALT or AST) are more than 2.5 times higher than the normal upper limit
  • Your kidney filtering rate is below 60 mL/min, suggesting reduced kidney function
  • You have low sodium levels in your blood
  • You are pregnant or breastfeeding
  • You are a woman who could become pregnant and are unwilling to use an acceptable form of contraception during the study
  • You have a history of psychosis or are currently having thoughts of suicide
  • You have major depression that is likely to need new or changed treatment during the study
  • You have been assessed as having Borderline Personality Disorder using a specific screening tool used by the study
  • You currently use nicotine products (such as cigarettes or vaping) and have not been using them at the same level for at least 12 weeks
  • You have taken part in another clinical trial involving an experimental drug, device, or biological treatment within the last month
  • You have any other significant illness, condition, or are taking a medication that the study doctor believes could affect your safety or the study results

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 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Elizabeth A Lawson, MD, Massachusetts General Hospital

Phone: 617-726-0047

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 2
Registry
ClinicalTrials.gov
Start date
7 March 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Binge Frequency

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: 26 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