ObesityPhase 4NCT06605703
A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)
A Phase 4 study testing WW Clinic, Bupropion-Naltrexone and Bupropion-Naltrexone-Metformin in people with Obesity and Overweight, run by WW International Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- WW Clinic, Bupropion-Naltrexone and Bupropion-Naltrexone-Metformin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to 5 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Previous hx of BMI of >30 or BMI of >27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
- Currently taking Wegovy, Ozempic, Mounjaro or Zepbound and have been for at least 6 months
- At least 15% body weight loss since taking Wegovy, Ozempic, Mounjaro, or Zepbound
- Willing to stop taking their GLP-1 medication or is discontinuing due to circumstances such as access, cost, coverage, choice, or any other reason
- Ability to provide informed consent prior to any trial-related activities
- Able to read and write in English
Who cannot join
- BMI <22 kg/m2
- Diabetes
- Previous surgical obesity treatment
- Currently pregnant or intending to become pregnant during the study
- Breastfeeding
- History of seizures or epilepsy
Show all 24Show fewer
- Current opioid use or in acute opioid withdrawal
- Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs
- History of glaucoma
- Uncontrolled hypertension
- Severe renal impairment and/or Chronic kidney disease stage III or GFR <60
- Acute hepatitis or liver failure
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis
- Use of antipsychotic medications or opiod analgesics
- Current or previous history of anorexia or bulimia nervosa
- Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight
- Current SSRI, SNRI, mood stabilizer, amphetamine, or corticosteroid use
- Current diagnosis of hyper or hypothyroidism or current use of thyroid replacement medicine
- Current use of beta blockers
- Current use of depo shot (medroxyprogesterone acetate) for birth control
- Current diagnosis of Cushing's disease or syndrome
- Current use of Monoamine Oxidase Inhibitors (MAOIs)
- Known hypersensitivity to bupropion, naltrexone, or metformin
- Any other reason rendering a participant unsuitable for trial participation, as determined by a clinician or study investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparative Effectiveness of Step-down Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide: A Randomized Controlled Trial (GLP1 Transition 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.
- Conditions
- Obesity, Overweight
- Being tested
- WW Clinic, Bupropion-Naltrexone, Bupropion-Naltrexone-Metformin
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WW ClinicBehavioural
Telehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW.
Bupropion-NaltrexoneDrug
Bupropion-Naltrexone
Bupropion-Naltrexone-MetforminDrug
Bupropion-Naltrexone-Metformin
| Study group | Role | What they receive |
|---|---|---|
| WW Clinic - No medications | Experimental | Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive no medications. Receives: Behavioral: WW Clinic |
| WW Clinic + Meds v1 | Experimental | Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic. Receives: Behavioral: WW Clinic; Drug: Bupropion-Naltrexone |
| WW Clinic + Meds v2 | Experimental | Participants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic. Receives: Behavioral: WW Clinic; Drug: Bupropion-Naltrexone-Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent body weight change at 12 weeks
Measurement of weight using a bluetooth body weight scale
Measured: Baseline, 12 weeks
Secondary outcomes (10)
Change in body weight (in kg or pounds) at 12 weeks
Measurement of weight using a bluetooth body weight scale
Measured: Baseline, 12 weeks
Physical Activity and Sedentary Behavior
The Global Physical Activity Questionnaire (GPAQ) is a 16 item scale.
Measured: Baseline, 12 weeks
Dietary Intake
Diet ID is powered by Diet Quality Photo Navigation (DQPN®). It is a digital toolkit and 1 component will be used in the study: ID assessment.
Measured: Baseline, 12 weeks
Habit/Automaticity
The Self-Report Behavioral Automaticity Index (SRBAI) is a 4-item measure.
Measured: Baseline, 12 weeks
Hunger VAS (Visual Analogue Scale)
The Hunger VAS (Visual Analogue Scale) is a reliable measure for appetite research. The Hunger VAS asks "How hungry did you feel over the past week" and is composed of a line with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants are asked to make a mark on the line corresponding to their feelings and quantification of the measurement is done by measuring the distance from the left end of the mark.
Measured: Baseline, 12 weeks
Impact on Quality of Life
The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is a validated self-report measure for an individual's perception of how their weight affects their day-to-day life
Measured: Baseline, 12 weeks
Well-being
The World Health Organization (WHO-5) Well-being Index consists of five statements, which respondents rate, in relation to the past two weeks, using a six-point Likert scale
Measured: Baseline, 12 weeks
Body Appreciation
The Body Appreciation Scale (BAS-2) measures individuals acceptance of, favorable opinions toward, and respect for their bodies. There are 10 items, each assessed on a scale from 1-never to 5-always. Higher scores indicate higher body appreciation.
Measured: Baseline, 12 weeks
Self-Compassion
The Self-Compassion Scale (SCS) is a 26-item measure of self-compassion that is psychometrically valid and theoretically coherent. The SCS consists of six subscales:
self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identified.
Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgment, isolation, and over-identification) and computing a grand mean of all six subscale means. Higher scores indicate greater self compassion.
Measured: Baseline, 12 weeks
Weight Bias
The Weight Bias Internalization Scale (WBIS-2F) has 13 items and responses are rated on a 7-point Likert scale(strongly disagree -strongly agree). Responses provide insight on the participant's internalized beliefs and feelings regarding their weight. There are two subscales: Weight-Related Distress (7 items; 7-13; Cronbach's alpha =0.910) and Weight-Related Self-Devaluation (6 items; 1-6; Cronbach's alpha =0.763). The WBIS-2F has been tested for validity in people with overweight and obesity and the two factor model demonstrated good to excellent fit with the data. Scores are calculated by taking an average of the response values. Questions 1,2,4,5, should be reverse scored before calculating the average. Higher scores indicating greater internalized weight bias.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start18 Sep 2024
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- WW International Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Kara Marlatt, WW International Inc
- Investigators
- Kara Marlatt, PhD, MPH, Principal investigator, WW International Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605703
- Sponsor's protocol ID
- GLP1 Transition Trial
- Status last verified
- Jan 2026
- First submitted
- 18 Sep 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Effectiveness of Step-down Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide: A Randomized Controlled Trial (GLP1 Transition Trial)
- ClinicalTrials.gov ID
- NCT06605703
- Acronym / sponsor ID
- GLP1 Transition Trial
- Conditions
- Obesity, Overweight
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- WW International IncIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WW Clinic - No medications | Experimental | Behavioral: WW ClinicParticipants in this group receive behavioral or lifestyle support from WW Clinic. They receive no medications. |
| WW Clinic + Meds v1 | Experimental | Behavioral: WW Clinic, Drug: Bupropion-NaltrexoneParticipants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic. |
| WW Clinic + Meds v2 | Experimental | Behavioral: WW Clinic, Drug: Bupropion-Naltrexone-MetforminParticipants in this group receive behavioral or lifestyle support from WW Clinic. They receive medications prescribed through WW Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Previous hx of BMI of >30 or BMI of >27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
- Currently taking Wegovy, Ozempic, Mounjaro or Zepbound and have been for at least 6 months
- At least 15% body weight loss since taking Wegovy, Ozempic, Mounjaro, or Zepbound
- Willing to stop taking their GLP-1 medication or is discontinuing due to circumstances such as access, cost, coverage, choice, or any other reason
Key exclusion criteria (24 listed)
- BMI <22 kg/m2
- Diabetes
- Previous surgical obesity treatment
- Currently pregnant or intending to become pregnant during the study
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WW ClinicTelehealth platform that specializes in medical weight management and integrates the behavioral and lifestyle support from WW. | Behavioural | WW Clinic + Meds v1, WW Clinic + Meds v2, WW Clinic - No medications |
| Bupropion-NaltrexoneBupropion-Naltrexone | Drug | WW Clinic + Meds v1 |
| Bupropion-Naltrexone-MetforminBupropion-Naltrexone-Metformin | Drug | WW Clinic + Meds v2 |
Primary outcome
Percent body weight change at 12 weeks
Time frame: Baseline, 12 weeks
Measurement of weight using a bluetooth body weight scale
10 secondary outcomes
Change in body weight (in kg or pounds) at 12 weeks
Time frame: Baseline, 12 weeks
Physical Activity and Sedentary Behavior
Time frame: Baseline, 12 weeks
Dietary Intake
Time frame: Baseline, 12 weeks
Habit/Automaticity
Time frame: Baseline, 12 weeks
Hunger VAS (Visual Analogue Scale)
Time frame: Baseline, 12 weeks
Impact on Quality of Life
Time frame: Baseline, 12 weeks
Well-being
Time frame: Baseline, 12 weeks
Body Appreciation
Time frame: Baseline, 12 weeks
Self-Compassion
Time frame: Baseline, 12 weeks
Weight Bias
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Marlatt, PhD, MPH principal investigator
WW International Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing WW Clinic, Bupropion-Naltrexone and Bupropion-Naltrexone-Metformin in people with Obesity and Overweight, run by WW International Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent body weight change at 12 weeks (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.