Weight Management Treatments for Obesity

Overseen By Michelle I Cardel, PhD, RD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Michelle Cardel, PhD, MS, RD

Must be taking: GLP-1 medications

Must not be taking: Antipsychotics, Opioids, SSRIs, SNRIs

Disqualifiers: Diabetes, Pregnancy, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

225 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking your GLP-1 medication (like Wegovy, Ozempic, Mounjaro, or Zepbound) to participate in this trial. The trial is specifically for those who are willing to discontinue these medications.

What data supports the effectiveness of the drug Bupropion-Naltrexone for weight management?

Research shows that the combination of naltrexone and bupropion, known as Contrave, leads to significant weight loss in obese adults when combined with lifestyle changes. In several studies, participants lost an average of 11-22 pounds (5-9 kg) over a year, and there were improvements in health markers related to heart and metabolism. ^{1 2 3 4 5}

Is the combination of naltrexone and bupropion safe for weight management in humans?

Naltrexone and bupropion, used together for weight management, have been generally well tolerated in clinical trials, with nausea being the most common side effect. These trials showed that the combination is safe for use in adults who are obese or overweight with related health issues. ^{1 3 4 5 6}

How does the drug naltrexone/bupropion differ from other obesity treatments?

Naltrexone/bupropion is unique because it combines two medications, naltrexone and bupropion, to help with weight loss and maintenance, especially in adults who are obese or overweight with related health issues like diabetes or high blood pressure. This combination works by affecting the brain's reward system and appetite control, and it is used alongside lifestyle changes such as diet and exercise. ^{2 3 4 5 6}

What is the purpose of this trial?

The study compares the effectiveness of treatment options for weight management after discontinuing semaglutide and tirzepatide. The primary outcome is absolute and percentage weight change at 12-weeks.

Research Team

Michelle Cardel, PhD, RD

Principal Investigator

WW International Inc

Eligibility Criteria

This trial is for individuals who have been using semaglutide or tirzepatide for obesity but are stopping these medications. Participants should be adults looking to manage their weight post-discontinuation.

Inclusion Criteria

Able to read and write in English

Ability to provide informed consent prior to any trial-related activities

I have had a BMI over 30, or over 27 with a condition like high blood pressure.

Exclusion Criteria

I am currently taking beta blockers.

Breastfeeding

BMI <26 kg/m2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavioral or lifestyle support from WW Clinic with or without medications for weight management

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bupropion-Naltrexone
• Bupropion-Naltrexone-Metformin
• WW Clinic

Trial Overview The study examines three treatments: a combination of Bupropion-Naltrexone-Metformin, just Bupropion-Naltrexone, and a Weight Watchers Clinic program. The goal is to see which helps maintain or reduce weight after stopping GLP-1 meds over 12 weeks.

Participant Groups

Group I: WW Clinic - No medications Experimental Treatment 1 Intervention

Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive no medications.

Group II: WW Clinic + Meds v2 Experimental Treatment 2 Interventions

Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.

Group III: WW Clinic + Meds v1 Experimental Treatment 2 Interventions

Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic.

Who Is Running the Clinical Trial?

Michelle Cardel, PhD, MS, RD

Lead Sponsor

Trials

2

Recruited

330+

Findings from Research

Contrave, a combination of naltrexone and bupropion, is being tested in Phase III clinical trials for obesity treatment, showing promising efficacy in preliminary studies.

Orexigen Therapeutics, the company behind Contrave, is currently working to address safety concerns raised by the FDA as they plan their next steps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACS chemical neuroscience molecule spotlight on contrave. Mercer, SL.[2021]

Naltrexone/bupropion ER, marketed as Contrave, is a newly approved medication specifically designed for chronic weight management in obese adults.

This combination therapy targets both appetite suppression and energy expenditure, offering a new option for individuals struggling with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone/Bupropion ER (Contrave): Newly Approved Treatment Option for Chronic Weight Management in Obese Adults. Sherman, MM., Ungureanu, S., Rey, JA.[2020]

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]

Contrave, a combination of naltrexone and bupropion, was shown to be effective for weight loss in a large study involving 4536 adults over 56 weeks, with participants losing an average of 11-22 lbs (5-9 kg) compared to placebo.

In addition to weight loss, Contrave also led to significant improvements in cardiometabolic markers, highlighting its potential benefits beyond just weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone/bupropion for the treatment of obesity and obesity with Type 2 diabetes. Apovian, CM.[2016]

Naltrexone/bupropion (Mysimba) is an effective treatment for adults who are obese or overweight with at least one weight-related health issue, and it is intended to be used alongside diet and lifestyle changes.

The combination product was licensed by the European Medicines Agency in 2015 and has recently been introduced in the UK, indicating its recognized safety and efficacy in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone/bupropion for obesity. [2018]

In 56-week phase III trials, naltrexone extended-release/bupropion extended-release (Contrave) significantly reduced body weight compared to placebo, with many patients achieving weight loss of 5% or more.

The treatment also led to notable improvements in cardiometabolic risk factors and glycated hemoglobin levels in overweight or obese adults with type 2 diabetes, and was generally well tolerated, with nausea being the most common side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone ER/Bupropion ER: A Review in Obesity Management. Greig, SL., Keating, GM.[2018]

References

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

ACS chemical neuroscience molecule spotlight on contrave. [2021]

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

Naltrexone/Bupropion ER (Contrave): Newly Approved Treatment Option for Chronic Weight Management in Obese Adults. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Naltrexone/bupropion for the treatment of obesity and obesity with Type 2 diabetes. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Naltrexone/bupropion for obesity. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Naltrexone ER/Bupropion ER: A Review in Obesity Management. [2018]