NB Medication for Weight Management After Bariatric Surgery

Recruiting in New Haven (>99 mi)

Overseen By Valentina Ivezaj, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Yale University

Must not be taking: MAOI, Opiates, Weight loss drugs

Disqualifiers: Seizures, Bulimia, Hypertension, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test the effectiveness of naltrexone/bupropion medication as a maintenance therapy for the treatment of loss-of-control eating and weight loss following bariatric surgery. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they are contraindicated with the trial medication, such as MAOIs or opiates. If you are currently using other weight loss medications, you will also need to stop those.

Is naltrexone/bupropion (NB) safe for humans?

Naltrexone/bupropion (NB) has been studied for weight management and is generally well tolerated in humans, including those with obesity and those taking antidepressants. The combination has been evaluated in several trials, showing no significant difference in serious adverse events compared to placebo. ^{1 2 3 4 5}

How does the drug naltrexone/bupropion differ from other weight management options after bariatric surgery?

Naltrexone/bupropion is unique because it targets brain systems involved in food cravings and mood, which can help manage weight by reducing food intake and cravings. This combination drug is also used for chronic weight management and has shown effectiveness in promoting weight loss in patients with obesity, even when they are on other medications like antidepressants. ^{1 2 4 5 6}

Research Team

Valentina Ivezaj, Ph.D.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults aged 18-70 who've had bariatric surgery, are experiencing loss-of-control eating post-surgery, and responded to initial treatment. Participants must be healthy with controlled medical conditions and not using drugs or heavy alcohol. Pregnant women, those with certain heart diseases, uncontrolled diabetes or hypertension, seizure risks, severe psychiatric disorders, or allergies to the study medications cannot join.

Inclusion Criteria

I started losing control over eating 6 months post-bariatric surgery and responded well to a 4-month treatment.

Read, comprehend, and write English at a sufficient level to complete study-related materials.

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

Exclusion Criteria

You have a history of eating disorders such as anorexia or bulimia.

You have a mental health condition that requires hospitalization or intensive treatment, such as bipolar disorder, psychosis, or severe depression.

I have gallbladder disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive naltrexone/bupropion medication or placebo as maintenance therapy for loss-of-control eating and weight management

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Naltrexone and Bupropion (NB) medication
• Placebo

Trial Overview The study tests if Naltrexone/Bupropion (NB) medication helps maintain weight loss and control overeating after bariatric surgery better than a placebo. It's for those who initially responded well to treatments and will compare long-term outcomes between the NB medication group and the placebo group over a period of up to 15 months.

Participant Groups

Group I: Naltrexone+Bupropion Medication Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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+

Findings from Research

Naltrexone/bupropion, an investigational weight loss medication, resulted in a significant mean weight loss of 4.7% after one year in obese patients, with 26-33% of participants achieving at least 5% weight loss compared to placebo.

In addition to weight loss, naltrexone/bupropion improved various health markers, including waist circumference and triglyceride levels, and reduced hemoglobin A1c by approximately 0.5% in patients with diabetes, although it had some common side effects like nausea and dizziness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone/bupropion: an investigational combination for weight loss and maintenance. Makowski, CT., Gwinn, KM., Hurren, KM.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Extended-release naltrexone/bupropion is safe and effective among subjects with type 2 diabetes already taking incretin agents: a post-hoc analysis of the LIGHT trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Naltrexone/bupropion: an investigational combination for weight loss and maintenance. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Drug safety evaluation of naltrexone/bupropion for the treatment of obesity. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Psychiatric Safety and Weight Loss Efficacy of Naltrexone/bupropion as Add-on to Antidepressant Therapy in Patients with Obesity or Overweight. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Naltrexone/bupropion for obesity: an investigational combination pharmacotherapy for weight loss. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis. [2021]