Weight Management Treatments for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new methods to manage weight for individuals who have stopped using medications like Wegovy or Ozempic. It compares three approaches: using special medications (such as the combination drug Bupropion-Naltrexone), combining medications with support from a weight management clinic, and receiving clinic support without medications. The goal is to determine which method helps maintain or continue weight loss over 12 weeks. This trial may suit those who have lost significant weight with these medications, are willing to stop taking them, and have conditions like high blood pressure or sleep apnea. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand its benefits for more patients.
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 is the safety track record for these treatments?
Previous studies have shown that the combination of bupropion and naltrexone, often sold under the brand name Contrave, presents no heart-related safety concerns when used for up to 12 months. This indicates that the treatment is generally well-tolerated with no major heart risks. Additionally, no evidence suggests that this medication can be abused.
For the combination of bupropion, naltrexone, and metformin, specific safety data is less available. However, studies have shown that bupropion and naltrexone together aid in weight loss without significant safety issues.
This trial is in Phase 4, indicating that the FDA has approved the treatments for other uses. Phase 4 trials typically assess the effectiveness and safety of these treatments in a larger population. While the treatments are expected to be safe for most people, ongoing monitoring helps identify any rare side effects.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for obesity because they combine medications like Bupropion-Naltrexone and Metformin with behavioral support from the WW Clinic. Unlike standard treatments that often focus solely on medication or lifestyle changes, this approach integrates both to potentially enhance effectiveness. The Bupropion-Naltrexone-Metformin combination is particularly promising as it targets multiple pathways involved in weight management, which might offer a more comprehensive solution compared to single-action treatments. Additionally, the inclusion of the WW Clinic's support could improve long-term adherence and lifestyle changes, setting it apart from many current options.
What evidence suggests that this trial's treatments could be effective for weight management?
Research has shown that bupropion-naltrexone, one of the treatments in this trial, can aid in weight loss. In one study, participants lost an average of 9.5% of their body weight over 56 weeks, a significant reduction compared to those not taking the drug. Adding metformin to bupropion-naltrexone, another treatment option in this trial, might help maintain weight loss longer, as metformin can support continued weight reduction.
Conversely, the WW Clinic program, also under study in this trial, has demonstrated impressive results. A recent study found that participants in this program lost up to 21% of their body weight over 12 months. This suggests that the WW Clinic can be highly effective for long-term weight management. Overall, these treatments have shown promising results in helping people manage their weight effectively.12678Who Is on the Research Team?
Michelle Cardel, PhD, RD
Principal Investigator
WW International Inc
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive behavioral or lifestyle support from WW Clinic with or without medications for weight management
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bupropion-Naltrexone
- Bupropion-Naltrexone-Metformin
- WW Clinic
Find a Clinic Near You
Who Is Running the Clinical Trial?
Michelle Cardel, PhD, MS, RD
Lead Sponsor