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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the medication lisdexamfetamine (Vyvanse) can help manage loss-of-control eating and weight after bariatric surgery. Participants will receive either the medication or a placebo (a pill with no active ingredients) to determine if the medication outperforms the placebo. The trial seeks individuals who underwent weight loss surgery, such as gastric bypass or sleeve gastrectomy, about ten months ago and continue to struggle with overeating despite previous treatment. Participants should not have certain medical conditions, such as untreated high blood pressure or diabetes. The trial lasts up to 15 months, including a 3-month treatment period and a 12-month follow-up. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lisdexamfetamine is generally safe for patients, with various studies confirming its safety. Some research suggests that after bariatric surgery, the body might absorb more of the drug's active component due to surgical changes. However, the drug's movement through the body appears similar in both individuals who have undergone bariatric surgery and those who have not.

While side effects can occur, they are usually mild to moderate. Common side effects may include dry mouth, trouble sleeping, or a fast heartbeat. Lisdexamfetamine is already used to treat conditions like ADHD, which supports its safety for humans. The study's later stages indicate existing evidence supporting its safety for the intended purpose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about lisdexamfetamine for post-bariatric surgery weight control because it offers a unique approach compared to existing options. While most treatments focus on diet, lifestyle changes, or other medications like orlistat and phentermine, lisdexamfetamine works differently by targeting neurotransmitters in the brain that influence appetite and energy expenditure. This mechanism could help patients maintain their weight loss more effectively after surgery. Additionally, lisdexamfetamine's active ingredient, lisdexamfetamine dimesylate, is known for its use in other conditions, which gives researchers optimism about its potential benefits for weight control.

What evidence suggests that lisdexamfetamine might be an effective treatment for weight control after bariatric surgery?

Research has shown that lisdexamfetamine, a medication often used for Attention Deficit Hyperactivity Disorder (ADHD), can improve focus and self-control. In this trial, participants will receive either lisdexamfetamine or a placebo. After bariatric surgery, studies have found that the level of dexamphetamine, the active component of lisdexamfetamine, increases in the body. This increase suggests that lisdexamfetamine might be more effective for patients post-surgery. The higher levels could help manage weight and eating habits by enhancing focus and reducing impulsive behavior. These findings indicate that using lisdexamfetamine after surgery could lead to better weight management. ^{1 2 3 4 6}

Who Is on the Research Team?

Carlos Grilo, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

I am allergic to LDX or similar stimulant medications.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39497274/

Effect of bariatric surgery on the pharmacokinetics of drugs ... Conclusion: Bariatric surgery may increase the systemic exposure of dexamphetamine after intake of lisdexamphetamine. Patients using ...

2. experts.umn.edu experts.umn.edu/files/284468382/s11695-020-04969-4.pdf

Lisdexamfetamine Pharmacokinetic Comparison Between ... This meta-analysis was designed to eval- uate the impact of ADHD on bariatric surgery outcomes. Data showed that while patients with ADHD did ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03497169

Study Details | NCT03497169 | Bariatric Surgery and ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/bcpt.14099

Effect of bariatric surgery on the pharmacokinetics of drugs ... We found increased concentrations of dexamphetamine after surgery in patients using lisdexamphetamine but did not find such changes after intake ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34291361/

Lisdexamfetamine Pharmacokinetic Comparison Between ... The pharmacokinetic parameters between the RYGB and NCS groups were found to be equivalent for lisdexamfetamine and d-amphetamine.

6. clinicaltrial.be clinicaltrial.be/en/details/176718?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Pharmacological and Behavioral Treatment After Bariatric... This study will test the effectiveness of lisdexamfetamine medication as a treatment for loss-of-control eating and weight following ...