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Weight Management Treatments for Obesity
Phase 4
Recruiting
Led By Michelle Cardel, PhD, RD
Research Sponsored by Michelle Cardel, PhD, MS, RD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older
Previous history of BMI of >30 or BMI of >27 with one or more weight-related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
Must not have
Current use of beta blockers
Current diagnosis of Cushing's disease or syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial compares different ways to help people manage their weight after they stop taking certain medications. They will measure the weight change after 12 weeks to see which treatment works best.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include nausea, headaches, constipation from the medication combinations, and potential mood changes due to Bupropion. The WW Clinic program may not have direct medical side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have had a BMI over 30, or over 27 with a condition like high blood pressure.
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I have been on Wegovy, Ozempic, Mounjaro, or Zepbound for at least 6 months.
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I have lost at least 15% of my body weight using Wegovy, Ozempic, Mounjaro, or Zepbound.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking beta blockers.
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I have been diagnosed with Cushing's disease or syndrome.
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I am currently using opioids or experiencing withdrawal.
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I have a thyroid condition or take thyroid medication.
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I have diabetes.
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I have had surgery for obesity.
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I have a history of seizures or epilepsy.
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I recently stopped using alcohol, benzodiazepines, barbiturates, or antiepileptic drugs.
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I have a history of glaucoma.
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My kidney function is severely impaired.
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My blood pressure is not controlled by medication.
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I am currently taking antipsychotic medications or opioid painkillers.
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I have used vomiting or laxatives to control my weight in the last 28 days.
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I do not have acute hepatitis or liver failure.
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I am currently taking medication for mood, attention, or inflammation.
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I have a condition where my body produces too much acid, including from diabetes.
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I am currently taking Monoamine Oxidase Inhibitors (MAOIs).
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I am allergic to bupropion, naltrexone, or metformin.
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I am currently using the depo shot for birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent body weight change at 12 weeks
Secondary study objectives
Body Appreciation
Change in body weight (in kg or pounds) at 12 weeks
Dietary Intake
+7 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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 Location
Who is running the clinical trial?
Michelle Cardel, PhD, MS, RDLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Obesity
100 Patients Enrolled for Obesity
Michelle Cardel, PhD, RDPrincipal InvestigatorWW International Inc
3 Previous Clinical Trials
193 Total Patients Enrolled
2 Trials studying Obesity
109 Patients Enrolled for Obesity
Rebecca Jones, PhDPrincipal InvestigatorWW International Inc