NB Medication for Weight Management After Bariatric Surgery

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether naltrexone/bupropion (NB medication) can help manage weight and reduce loss-of-control eating after bariatric surgery. Participants will receive either the medication or a placebo to determine which is more effective for long-term results. Ideal candidates had gastric bypass or sleeve surgery around ten months ago and began struggling with uncontrolled eating about six months post-surgery. The study spans approximately 15 months, including treatment and follow-up. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to significant advancements in post-surgery care.

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

Research has shown that the combination of naltrexone and bupropion (NB) is generally well-tolerated by patients. One study found nausea and constipation to be the most common side effects. Specifically, 10.5% of participants reported nausea after 4 months, and 5.7% after 6 months. Constipation was reported by 6.3% of participants. Many people find these side effects manageable.

Another study indicated that NB can lead to significant weight loss when combined with lifestyle changes. However, high drop-out rates suggest that some people might find the side effects difficult to handle.

NB is already approved for weight management in other situations, indicating a known safety profile. Overall, while some side effects are possible, NB is considered safe enough for testing in additional uses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the combination of Naltrexone and Bupropion for weight management after bariatric surgery because it offers a novel approach compared to current options. Unlike standard treatments that primarily focus on diet and lifestyle changes, this medication combines two active ingredients that work together to target the brain's reward system and control cravings, potentially leading to more effective weight loss. Additionally, while many existing therapies require long-term behavioral changes, this medication could provide more immediate support for patients struggling to maintain weight loss after surgery.

What evidence suggests that naltrexone/bupropion medication might be an effective treatment for weight management after bariatric surgery?

Research has shown that the medication combination of naltrexone and bupropion (NB), which participants in this trial may receive, can help manage weight after bariatric surgery. One study found that 63% of patients who took NB after surgery lost an average of 8.8% of their weight over 12 months. Another study found that using NB along with lifestyle changes led to significant weight loss at both 6 and 12 months. This combination of medications appears more effective for weight loss than using either one alone. These findings suggest that NB medication could help maintain weight loss and control eating habits after surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Valentina Ivezaj, Ph.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40897847/

Real world efficacy of naltrexone/bupropion for weight ...

At 12-months, 38.5% of surgery-naive patients and 63.0% of post-MBS patients had continued NB, with median weight loss of 8.8% (5.0, 16.7) and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12148336/

The Effectivity and Safety of Naltrexone/Bupropion in Patients ...

Conclusion. NB treatment combined with lifestyle intervention results in significant weight loss after 6 and 12 months. Despite high discontinuation rates due ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02616315

Study Details | NCT02616315 | Efficacy of Naltrexone HCl ...

NB is being tested to determine its effect on weight loss in obese participants post bariatric surgery. The study will enroll approximately 60 ...

4.

researchgate.net

researchgate.net/publication/386262946_Real_World_Efficacy_of_NaltrexoneBupropion_for_Weight_Management_in_Obesity_and_After_Bariatric_Surgery

(PDF) Real World Efficacy of Naltrexone/Bupropion for ...

At 12-months, 38.5% of surgery-naive patients and 63.0% of post-MBS patients had continued NB, with median weight loss of 8.8% (5.0, 16.7) and ...

5.

dmsjournal.biomedcentral.com

dmsjournal.biomedcentral.com/articles/10.1186/s13098-024-01319-7

The effects of bupropion alone and combined with naltrexone ...

Bupropion/naltrexone combination produced significant weight loss when compared to either medication alone. The mechanisms through which ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04399395

Naltrexone/Bupropion (Mysimba) to Optimize Weight ...

This pilot study will examine the effect of naltrexone/bupropion and lifestyle advice versus lifestyle advice alone for 7 months in patients with a suboptimal ...

7.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1111/cob.12724

The real‐world relationship between naltrexone/bupropion ...

The most common adverse events reported were nausea (10.5% of participants at 4 months and 5.7% of participants at 6 months), constipation (6.3% ...