A Phase 4 interventional study of GLP-1 dose reduction and non-GLP weight loss medication in Obesity & Overweight and Cardiometabolic Health Indicators, sponsored by Jing Luo. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Jing Luo · Phase 4, Interventional, and Treatment
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The purpose of this research is to compare weight loss among 3 groups:
The investigators want to see if the second and third options are effective at weight loss maintenance.
This study will include a total of 60 participants. Participants will be randomly assigned to one of the three study groups.
The goals of this current study are to:
There are 3 on-site visits: at the start, and then 6 and 12 months. The study team will do monthly phone calls in between those visits. At the on-site visits the study team will do various physical measures and collect blood for lab testing and provide participants with counseling to help with weight loss.
The study team will instruct participants in a home-based resistance exercise regimen to help maintain muscle mass. This will include exercises such as: sit-to-stand, mini-squats, calf raises, leg extension, wall press-up, and bicep curls two to three times a week. If these exercises are deemed too easy, participants may choose to do regular pushups, planks, lunges and/or add a resistance band.
11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.
This study's planned enrollment of 60 is below the median of 67 across 9,016 interventional studies indexed under Obesity.
Browse Obesity studies →Jing Luo is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 5, 2026. See what changed
Participant Inclusion Criteria:
Participant Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Maintenance of high-potency GLP-1 based therapy. Participants will continue their dose at enrollment for the entire duration of study follow-up. This is the current standard of care when the medication is covered and available.
Drug: Maintenance of GLP-1 dose · Behavioral: Resistance exercise regimen · Behavioral: Lifestyle/nutrition counseling
GLP-1 dose reduction to lower-dose, alternate frequency. Participants on semaglutide at enrollment will gradually reduce their dose from 2.4mg to 1.7mg to 1.0mg to 0.5mg once a week to 0.5mg every other week. Participants on tirzepatide at baseline will gradually reduce their dose from 15mg to 12.5mg to 10mg to 7.5mg to 5mg once a week to 5mg every other week. Dose reductions are scheduled every 4 weeks.
Drug: GLP-1 dose reduction · Behavioral: Resistance exercise regimen · Behavioral: Lifestyle/nutrition counseling
After gradually reducing GLP-1 therapy, participants will start phentermine with topiramate. Participants will reduce their semaglutide or tirzepatide dosage following the schedule of the "low dose, alternate frequency" arm until either semaglutide is 0.5mg once a week or tirzepatide is 5mg once a week. Participants will then start phentermine at 15mg once a day. Four weeks later, they will add topiramate at 25mg once a day. Four weeks later, they will increase the phentermine dose to 30mg once a day. Four weeks later, they will increase topiramate to 50mg once a day. Participants who cannot tolerate or have contraindications to phentermine will be offered bupropion + naltrexone. Dosages for bupropion would start at 75mg twice a day (maintenance dose 150mg twice a day). Dosages for naltrexone would start at 25mg per day. For subjects where a review by the PI or Co-I suggest a favorable benefit/risk profile, an option would be provided to increase naltrexone to 25mg twice per day.
Drug: non-GLP weight loss medication · Behavioral: Resistance exercise regimen · Behavioral: Lifestyle/nutrition counseling
Participants in this intervention arm will receive a reduced GLP-1 dose compared to usual care.
Participants in this intervention arm will be switched to a non-GLP weight loss medication.
Participants in this arm will maintain their high-potency GLP-1 dosage.
All participants will be recommended to do a "low touch" home-based resistance exercise regimen. These strength exercises will include: sit-to-stand, mini-squats, calf raises, leg extension, wall press-up, bicep curls two to three times a week. If too easy for a particular subject, the study may recommend regular push ups, planks, lunges and/or add a resistance band.
Participants will be provided with guideline concordant weight loss maintenance education and counseling (i.e., calorie restriction, amount and intensity of physical activity, self-monitoring of weight, and measuring portion sizes).
This study also gives Semaglutide, Tirzepatide. No intervention listed here names it: that was found by reading the record.
Feasibility of recruitment and retention
The primary study endpoint is feasibility. This trial will be considered feasible if the study achieves: * ≥60% consent to approach rate. * ≥80% enrolled to consent rate. * A total of at least 60 participants (20 per study arm). * ≥80% protocol completion rate among enrolled participants at 6 months. * ≥70% protocol completion rate among enrolled participants at 12 months.
Time frame: Completion of participation, up to 12 months.
Acceptability of lower-dose, alternate frequency dosing or switching to non-incretin based weight loss therapy
Acceptability of the individual comparators will be based on participant responses to a survey questionnaire developed for this study. The proposed comparators will be considered acceptable if at the 6-month study visit: * ≥70% of patients would recomend the intervention to other patients using incretin based therapies for weight loss, OR * ≥70% of patients agree or strongly agree that the randomly assigned intervention has "helped me maintain me weight loss or level of function".
Time frame: 6-month study visit
Feasibility of measuring percent change in body weight during follow-up
The study team will consider this feasible if ≥80% of participants have a valid, non-missing body weight measurement from the electronic health record in the 4-week window centered around the 6-month study visit.
Time frame: 6-month study visit
Plan to share: Yes — De-identified individual participant level data generated from the PI's institution (UPMC) will be shared to eligible individuals by request in writing to the PI and through deposit in Zenodo (see below). Data sharing at the de-identified individual level will be sufficient to replicate the study results. These data made available must be under terms and conditions consistent with the informed consent provided by individual participants, and as approved by the awardees' Institutional Review Board (IRB) and any local, state and Federal laws and regulations
Time frame: Data may be made available at the end of the performance period, or time of an associated publication. It will be available for up to 5 years.
Access criteria: Anyone in the general public can search and identify data on Zenodo's website. Data will be made available by a data repository only after approval. Data from this trial (deidentified individual participant data) will be restricted to medical professionals who submit a data access request.
Data sharing details ↗ · zenodo.org
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Apr 2027, 4 months later.
Of 190 non-industry phase 4 interventional studies under Obesity, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 4 months is below that.
Counting every sponsor, half of 210 studies reached it within 31 months; a quarter within 15 and three quarters within 51.
Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Dec 2026, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Semaglutide · Tirzepatide
Jing Luo