Weight Management Treatments for Obesity
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
13456How 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.
23456Eligibility 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
+4 more
Exclusion Criteria
I am currently taking beta blockers.
Breastfeeding
BMI <26 kg/m2
+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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
WW International, IncNYC, NY
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Who Is Running the Clinical Trial?
Michelle Cardel, PhD, MS, RDLead Sponsor
References
ACS chemical neuroscience molecule spotlight on contrave. [2021]Contrave is an investigational fixed-dose combination drug of naltrexone and bupropion currently in Phase III clinical trials for the treatment of obesity. Orexigen Therapeutics, Inc. has demonstrated efficacy of their product and is currently addressing FDA safety concerns and deciding future actions.
Naltrexone/Bupropion ER (Contrave): Newly Approved Treatment Option for Chronic Weight Management in Obese Adults. [2020]Naltrexone/bupropion ER (Contrave): newly approved treatment option for chronic weight management in obese adults.
Naltrexone/bupropion: an investigational combination for weight loss and maintenance. [2022]Naltrexone/bupropion is an investigational combination for weight loss and maintenance in patients who are obese or have a BMI ≥ 27 kg/m(2) with comorbid diabetes, hypertension or hyperlipidemia. Pooled results from four phase 3 trials reveal placebo-subtracted mean weight loss of 4.7% (range 3.2-5.2%) with naltrexone/bupropion after 1 year (p
Naltrexone/bupropion for the treatment of obesity and obesity with Type 2 diabetes. [2016]Contrave(®) is a combination of naltrexone hydrochloride extended release and bupropion hydrochloride extended release for the treatment of obesity, and is used with lifestyle modification. Its safety and efficacy were assessed in four randomized, double-blind, placebo-controlled, 56-week Phase III clinical trials in 4536 adult subjects: COR-1, COR-II, COR-BMOD and COR-DM. All four studies demonstrated statistically significant and clinically meaningful weight loss following up to 52 weeks of treatment with naltrexone/bupropion compared with placebo. The average weight loss from baseline across the four studies was approximately 11-22 lbs (5-9 kg). Results show the efficacy of Contrave for weight loss, as well as significant improvements in cardiometabolic markers. This review focuses on the four studies, their outcomes and the mechanism of action of Contrave.
Naltrexone/bupropion for obesity. [2018]Naltrexone/bupropion (Mysimba - Orexigen Therapeutics Ireland Limited) is a fixed-dose combination product for the treatment of adults who are obese or overweight with at least one weight-related comorbidity, as an adjunct to diet and lifestyle modifications. Originally licensed by the European Medicines Agency (EMA) in 2015, it has recently been launched in the UK. Here, we review the evidence for its efficacy and safety and consider its place in therapy.
Naltrexone ER/Bupropion ER: A Review in Obesity Management. [2018]Oral naltrexone extended-release/bupropion extended-release (naltrexone ER/bupropion ER; Contrave(®), Mysimba(™)) is available as an adjunct to a reduced-calorie diet and increased physical activity in adults with an initial body mass index (BMI) of ≥ 30 kg/m(2) (i.e. obese) or a BMI of ≥ 27 kg/m(2) (i.e. overweight) in the presence of at least one bodyweight-related comorbidity, such as type 2 diabetes mellitus, hypertension or dyslipidaemia. In 56-week phase III trials in these patient populations, oral naltrexone ER/bupropion ER 32/360 mg/day was significantly more effective than placebo with regard to percentage bodyweight reductions from baseline and the proportion of patients who achieved bodyweight reductions of ≥ 5 and ≥ 10%. Significantly greater improvements in several cardiometabolic risk factors were also observed with naltrexone ER/bupropion ER versus placebo, as well as greater improvements in glycated haemoglobin levels in obese or overweight adults with type 2 diabetes. Naltrexone ER/bupropion ER was generally well tolerated in phase III trials, with nausea being the most common adverse event. Thus, naltrexone ER/bupropion ER 32/360 mg/day as an adjunct to a reduced-calorie diet and increased physical activity, is an effective and well tolerated option for chronic bodyweight management in obese adults or overweight adults with at least one bodyweight-related comorbidity.