Lisdexamfetamine for Post-Bariatric Surgery Weight Control

Recruiting in Palo Alto (17 mi)

Overseen byCarlos Grilo, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Yale University

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing whether the drug lisdexamfetamine can help people who have had weight-loss surgery but still struggle with controlling their eating and weight. The study focuses on those who did not improve with initial treatments, to see if this medication works better.

Research Team

Carlos Grilo, PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults aged 18-64 who've had bariatric surgery (gastric bypass or sleeve gastrectomy) about ten months ago, struggle with loss-of-control eating post-surgery, and didn't respond to initial treatments. Participants must be in good health otherwise, not on certain medications including weight loss drugs or stimulants, and without severe psychiatric conditions or unstable medical disorders.

Inclusion Criteria

Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies)

Be available for participation in the study for up to 15 months (3-month treatment plus 12-month follow up)

Provide a signed and dated written informed consent prior to study participation

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Exclusion Criteria

I have a severe kidney, liver, nerve, lung condition, or another serious health issue.

My blood pressure is high and not under control.

You have a history of eating disorders like anorexia or bulimia.

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Treatment Details

Interventions

Lisdexamfetamine Dimesylate (Other)
N/A (Other)
Placebo (Other)

Trial OverviewThe study tests if lisdexamfetamine can help control eating and manage weight better than a placebo in those who haven't improved after previous treatments following bariatric surgery. It's a controlled trial where participants are randomly given either the medication or a placebo.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lisdexamfetamine dimesylateExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Lisdexamfetamine Dimesylate is already approved in Canada for the following indications: