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.
What data supports the idea that Weight Management Treatments for Obesity is an effective drug?The available research shows that the drug combination of naltrexone and bupropion, known as Contrave, is effective for weight management in obese adults. In four major studies, people who took this drug lost an average of 11-22 pounds (5-9 kg) over a year, which was significantly more than those who took a placebo. Additionally, these studies reported improvements in health markers related to heart and metabolism. This suggests that Contrave is a promising option for weight loss when combined with lifestyle changes.12456
Is the drug used in the trial 'Weight Management Treatments for Obesity' a promising treatment?Yes, the drug naltrexone/bupropion is a promising treatment for obesity. It has been shown to help people lose weight and improve health markers like blood sugar and cholesterol when combined with diet and exercise.13456
What safety data exists for Bupropion-Naltrexone treatments for obesity?The safety of Bupropion-Naltrexone (Contrave, Mysimba) for obesity has been evaluated in several Phase III clinical trials, including COR-1, COR-II, COR-BMOD, and COR-DM, involving 4536 adult subjects. These studies demonstrated significant weight loss and improvements in cardiometabolic markers. The treatment was generally well tolerated, with nausea being the most common adverse event. The European Medicines Agency licensed it in 2015, and it has been launched in the UK. The trials showed that it is an effective and well-tolerated option for chronic weight management in obese adults or overweight adults with comorbidities.12346
Do I have to stop taking my current medications for the trial?Yes, you must stop taking your GLP-1 medication like Wegovy, Ozempic, Mounjaro, or Zepbound to participate in the trial. Additionally, you cannot be on certain other medications like SSRIs, SNRIs, mood stabilizers, amphetamines, corticosteroids, beta blockers, or thyroid replacement medicine.
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
I am 18 years old or older.
I have had a BMI over 30, or over 27 with a condition like high blood pressure.
I have been on Wegovy, Ozempic, Mounjaro, or Zepbound for at least 6 months.
I have lost at least 15% of my body weight using Wegovy, Ozempic, Mounjaro, or Zepbound.
Exclusion Criteria
I am currently taking beta blockers.
I have been diagnosed with Cushing's disease or syndrome.
I am currently using opioids or experiencing withdrawal.
I have a thyroid condition or take thyroid medication.
I have diabetes.
I have had surgery for obesity.
I have a history of seizures or epilepsy.
I recently stopped using alcohol, benzodiazepines, barbiturates, or antiepileptic drugs.
I have a history of glaucoma.
My kidney function is severely impaired.
My blood pressure is not controlled by medication.
I am currently taking antipsychotic medications or opioid painkillers.
I have used vomiting or laxatives to control my weight in the last 28 days.
I do not have acute hepatitis or liver failure.
I am currently taking medication for mood, attention, or inflammation.
I have a condition where my body produces too much acid, including from diabetes.
I am currently taking Monoamine Oxidase Inhibitors (MAOIs).
I am allergic to bupropion, naltrexone, or metformin.
I am currently using the depo shot for birth control.
Treatment Details
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
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
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 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.
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 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 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.