Lisdexamfetamine for Post-Bariatric Surgery Weight Control

Overseen By Valentina Ivezaj, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Yale University

Must not be taking: Weight loss drugs, MAOIs, SSRIs, ADHD meds

Disqualifiers: Seizures, Bulimia, Bipolar, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

60 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as those for weight loss, psychostimulants, ADHD medications, MAOIs, SSRIs, and strong inhibitors of CYP2D6. If you are on any of these, you would need to stop them to participate in the study.

How does the drug Lisdexamfetamine differ from other treatments for weight control after bariatric surgery?

Lisdexamfetamine (Vyvanse) is unique for post-bariatric surgery weight control as it is primarily used to treat ADHD and binge eating disorder, working by affecting chemicals in the brain that contribute to impulse control and hyperactivity. This mechanism may help manage eating behaviors, unlike traditional appetite suppressants or other weight management drugs used after bariatric surgery. ^{1 2 3 4 5}

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lisdexamfetamine or placebo to treat loss-of-control eating and improve weight outcomes

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Lisdexamfetamine Dimesylate
• N/A
• Placebo

Trial Overview The 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

Group I: Lisdexamfetamine dimesylate Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Lisdexamfetamine Dimesylate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vyvanse for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Moderate to severe binge eating disorder (BED)

Approved in European Union as Vyvanse for:

• Attention Deficit Hyperactivity Disorder (ADHD)

Approved in Canada as Vyvanse for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Moderate to severe binge eating disorder (BED)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Adjunctive Use of Appetite Suppressant Medications for Improved Weight Management in Bariatric Surgical Patients. [2019]

2. Portugal pubmed.ncbi.nlm.nih.gov

Lithium Intoxication after Bariatric Surgery: A Case Report. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Liraglutide 3.0 mg (Saxenda©) for Weight Loss and Remission of Pre-Diabetes. Real-World Clinical Evaluation of Effectiveness among Patients Awaiting Bariatric Surgery. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of liraglutide 3.0 mg treatment on weight loss in patients with weight regain after bariatric surgery. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Alcohol and bariatric surgery: review and suggested recommendations for assessment and management. [2017]