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Weight Management Treatments for Obesity

Recruiting in Palo Alto (17 mi)

Overseen byRebecca Jones, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

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

Prior Safety Data

Trial Summary

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.

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

Research Team

Michelle Cardel, PhD, RD

Principal Investigator

WW International Inc

Rebecca Jones, PhD

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

I am 18 years old or older.

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

See 4 more

Exclusion Criteria

I am currently taking beta blockers.

Breastfeeding

BMI <26 kg/m2

See 22 more

Trial 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 (Other)
Bupropion-Naltrexone-Metformin (Other)
WW Clinic (Other)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Group I: WW Clinic - No medicationsExperimental Treatment1 Intervention

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

Group II: WW Clinic + Meds v2Experimental Treatment2 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 v1Experimental Treatment2 Interventions

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Michelle Cardel, PhD, MS, RD

Lead Sponsor

Trials

Recruited

330+

Findings from Research

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]

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]