Obesity and Obesity-related Medical ConditionsMAINTAINNCT06734312
MAINTAIN (Mucosal AblatIoN Therapy After INcretins)
A study testing Gastric Fundal Mucosal Ablation (GFMA) in people with Obesity and Obesity-related Medical Conditions and Obesity and Overweight, run by Dr. Christopher McGowan at 2 sites in United States.
Trial summary
The purpose of this study is to assess the effect of gastric fundal mucosal ablation (GFMA) on weight trajectory following discontinuation of once-weekly semaglutide or tirzepatide in adults with obesity. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Obesity and Overweight, Obesity Prevention
- What is being tested?
- Gastric Fundal Mucosal Ablation (GFMA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 21-65
- Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤45 kg/m²
- Observed ≥ 10% TBWL with semaglutide or tirzepatide use for primary obesity therapy
- Subject did not experience >50% weight recurrence since discontinuation of semaglutide or tirzepatide
- Maintained a stable dose of semaglutide or tirzepatide for a minimum of 12 weeks
- Have recently discontinued or are planning to discontinue semaglutide or tirzepatide (≤ 24 weeks from last dose to time of study procedure)
Show all 9Show fewer
- No previous medical history of diabetes mellitus
- Willing and able to participate in the study procedures
- Understand and voluntarily sign the informed consent
Who cannot join
- Known diagnosis of type I or type II diabetes or a Hemoglobin A1c > 6.5% at time of screening
- Use of GLP-1 or GLP-1/GIP medication for the treatment of diabetes, rather than obesity.
- Use of anticoagulation, antithrombotic agents, and/or NSAIDs that cannot be discontinued for a minimum of 12 weeks
- Known bleeding diathesis that cannot be corrected through medical means.
- History of decompensated end-organ disease
- Unwillingness to abstain from the use of incretin mimetics during the study duration.
Show all 16Show fewer
- Unwillingness to abstain from the use of tobacco during the study duration
- Patients on any medications or supplements including those that may influence cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels
- History of any stomach manipulation (including repair of hiatal hernia or fundoplication) deemed unsafe by PI for GFMA
- Active disordered eating
- Patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason
- Known diagnosis of gastroparesis or functional dyspepsia
- Patients who are pregnant, who plan to become pregnant during study duration, or patients of child-bearing potential who refuse effective birth control methods (as approved by PI)
- Active H. pylori infection or history of H pylori without treatment and confirmation of eradication
- Active gastric ulceration.
- Use of concomitant medications known to induce weight loss (including but not limited to liraglutide, phentermine, phentermine/topiramate, bupropion/naltrexone, metformin)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
True You Weight Loss
Cary, North Carolina, 27513
Chase Wooley, BS, (984) 345-2988, Chase@trueyouweightloss.com
Shannon Casey, MS, (919) 391-7843, Shannon@trueyouweightloss.com
- Recruiting
True You Weight Loss
Cary, North Carolina, 27513
Shannon Casey, MS, 919-391-7843, Shannon@trueyouweightloss.com
Chase Wooley, BS, 984-345-2988, chase@trueyouweightloss.com
About this study
Official title: Gastric Fundal Mucosal Ablation for Weight Management in Patients Stopping Glucagon-like Peptide-1 Receptor Agonists
The purpose of this study is to assess the effect of gastric fundal mucosal ablation (GFMA) on weight trajectory following discontinuation of once-weekly semaglutide or tirzepatide in adults with obesity. In this study, GFMA will be performed on patients who have experienced > 10% weight loss with GLP-1 therapy and who plan to discontinue use of GLP-1 medications for the duration of the study.
Read the detailed description
Obesity is a multifactorial, chronic, and progressive disease of pandemic proportions. Incretin mimetics , such as semaglutide and tirzepatide, induce weight loss in adults with obesity, while also improving weight-related medical conditions, such as cardiac and renal disease. The beneficial effects on weight and metabolism require the continued presence of these medications, which have a half-life of approximately five to seven days. This concept was substantially illustrated in the STEP4 and SURMOUNT4 randomized controlled trials. In the STEP4 trial, adults with obesity were treated with semaglutide for a 20-week run-in, losing 10.6% of body weight, thereafter randomized 2:1 to continued semaglutide use vs placebo. Over the subsequent 48 weeks, the semaglutide arm lost an additional 7.9% of original body weight, whereas the placebo arm saw two-thirds the lost weight return. In the SURMOUNT-4 trial, adults with obesity were treated with tirzepatide for a 36-week run-in period, losing 20.9% of body weight, thereafter, randomized 1:1 for continued treatment or placebo. Over the subsequent 52 weeks, the treatment arm lost an additional 5.5% of body weight, whereas the placebo arm saw a return of approximately half the weight that had been lost. These observations present challenges for long-term obesity management when confronted by multiple reports showing high rates of discontinuation of incretin mimetics soon after initiation. These observations present challenges for long-term obesity management when confronted by multiple reports showing high rates of discontinuation of incretin mimetics soon after initiation. Gastric fundal mucosal ablation (GFMA) is a novel endoscopic approach to control appetite which uses hybrid argon plasma coagulation (HybridAPC) to ablate the superficial tissue of the gastric fundus to induce cell death and fibrotic remodeling. In an early safety and feasibility study of ten adults with obesity, GFMA reduced circulating levels of the only known hunger hormone in humans, ghrelin. This led to a measured suppression of inter-meal hunger and cravings, as well as improved confidence in the ability to resist cravings. In addition to reducing ghrelin-producing cell population within the fundus, GFMA induced significant fundal fibrin deposition. This resulted in a stiffer, less compliant fundus, reducing maximum tolerated volume of a standardized nutrient drink test, enhancing intra-meal satiation. Given that GFMA induces appetite control through both visceroceptive and hormonal mechanism, much like incretin mimetics, we hypothesize that GFMA can prevent or limit weight recurrence in adults who have stopped these medications after successful obesity treatment.
- Conditions
- Obesity and Obesity-related Medical Conditions, Obesity and Overweight, Obesity Prevention, Obesity Recidivism, GLP-1, Ablation Techniques
- Being tested
- Gastric Fundal Mucosal Ablation (GFMA)
- Keywords
- obesity, obesity and overweight, endoscopic bariatric therapy, ablation, gastric mucosal ablation, GMA, GFMA, glp-1, weight loss medications, weight loss, semaglutide, tirzepatide, hunger, appetite
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Fundal Mucosal Ablation (GFMA)Device
Endoscopic Gastric Fundal Mucosal Ablation (GFMA) after discontinuation of GLP-1 therapy
| Study group | Role | What they receive |
|---|---|---|
| Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy | Experimental | Subjects will undergo endoscopic Gastric Fundal Mucosal Ablation (GFMA) following following discontinuation of GLP-1 therapy. This will be performed by an experienced endoscopist specialized in bariatric endoscopy in a single endoscopic session. Receives: Device: Gastric Fundal Mucosal Ablation (GFMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Measure percent change in total body weight over time following endoscopic GFMA. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
Measured: 12 months
Secondary outcomes (9)
Rate of Adverse Events (AE)
Occurrence of Adverse Events along with AE Type, severity, and relationship to treatment.
Measured: Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
Quality of Life Assessment
Baseline quality of life assessment scores compared to follow-up quality of life assessment scores. Quality of life score assessed and measured by the Impact of Weight on Quality of Life-Lite questionnaire. Scoring for the questionnaire ranges from 0 (minimum) to 100 (maximum). Higher scores for the Impact of Weight on Quality of Life-lite questionnaire indicates higher quality of life.
Measured: 1 Month, 2 Months, 3 Months, 6 Months, 12 Months
Quality of Life Assessment
Baseline quality of life assessment scores compared to follow-up quality of life assessment scores. Quality of life score assessed and measured by the 36-Item Short Form Survey. Scoring for the questionnaire ranges from 0 (minimum) to 100 (maximum). Higher scores on the 36-Item Short Form Survey questionnaire indicates higher quality of life.
Measured: 1 Month, 2 Months, 3 Months, 6 Months, 12 Months
Appetite and Hunger Assessment
Baseline appetite and hunger assessment scores compared to follow-up appetite and hunger assessment scores. Appetite and hunger assessed and measured by the DAILY EATS questionnaire, which contains a numerical rating scale of 0-10 for each its 5 items. A higher score indicates greater hunger and appetite. A reduction in DAILY EATS score from baseline indicates a decrease in hunger and appetite levels, which is considered a positive outcome.
Measured: Month 1, Month 2, Month 3, Month 6, Month 12
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Measure percent change in total body weight over time following endoscopic GFMA. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
Measured: Month 1, Month 3, Month 6, Month 9
Change in Body Mass Index (BMI) from Baseline
Measure change in body mass index over time following endoscopic GFMA. BMI=(Weight in kg)/((Height in meters) ^2)
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Percent Weight Recurrence from Baseline
Measure percent recurrence in weight following endoscopic GFMA following discontinuation of semaglutide or tirzepatide.
% Weight recurrence = % of weight lost from semaglutide or tirzepatide that recurs after discontinuation
Measured: Month 1, Month 3, Month 6, Month 9, Month 12
Measured Proportion of Patients with weight recurrence
Measure percentage of patients with weight recurrence between <0%, 0-19.9%, 20-39.9%, 40-59.9%, 60-79.9%, 80-99.9%, vs 100% or more after GFMA.
Measured: 6 Months, 12 Months
Eating Behavior and Weight Management Self-Efficacy Assessment
Baseline eating behavior and weight management self-efficacy assessment scores compared to follow-up eating behavior and weight management self-efficacy scores measured by the WEL-SF questionnaire. WEL-SF is scored on a scale of 0-80 and includes 8 items measuring eating self-efficacy, which is the confidence one has in their ability to resist overeating. Higher WEL-SF scores indicate greater eating behavior self-efficacy and control. An increase in WEL-SF scores from baseline reflects an improvement in eating self-efficacy and is considered a positive outcome.
Measured: Month 1, Month 2, Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Christopher McGowan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Christopher McGowan, True You Weight Loss
- Investigators
- Christopher McGowan, MD, MSCR, Principal investigator, True You Weight Loss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734312
- Sponsor's protocol ID
- PS-004
- Acronym
- MAINTAIN
- Status last verified
- Jan 2025
- First submitted
- 10 Dec 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kumbhari V, Lehmann S, Schlichting N, Heinrich M, Kullnick Y, Retschlag U, Enderle M, Dietrich A, Khashab MA, Kalloo AN, Oberbach A. Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model. Gastrointest Endosc. 2018 Jul;88(1):175-184.e1. doi: 10.1016/j.gie.2018.02.022. Epub 2018 Feb 22.
PubMed 29476845Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.
PubMed 35441470Popoviciu MS, Paduraru L, Yahya G, Metwally K, Cavalu S. Emerging Role of GLP-1 Agonists in Obesity: A Comprehensive Review of Randomised Controlled Trials. Int J Mol Sci. 2023 Jun 21;24(13):10449. doi: 10.3390/ijms241310449.
PubMed 37445623
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Fundal Mucosal Ablation for Weight Management in Patients Stopping Glucagon-like Peptide-1 Receptor Agonists
- ClinicalTrials.gov ID
- NCT06734312
- Acronym / sponsor ID
- MAINTAIN / PS-004
- Conditions
- Obesity and Obesity-related Medical Conditions, Obesity and Overweight, Obesity Prevention, Obesity Recidivism, GLP-1, Ablation Techniques
- Keywords
- obesity, obesity and overweight, endoscopic bariatric therapy, ablation, gastric mucosal ablation, GMA, GFMA, glp-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dr. Christopher McGowanUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 Dec 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 purpose of this study is to assess the effect of gastric fundal mucosal ablation (GFMA) on weight trajectory following discontinuation of once-weekly semaglutide or tirzepatide in adults with obesity. In this study, GFMA will be performed on patients who have experienced > 10% weight loss with GLP-1 therapy and who plan to discontinue use of GLP-1 medications for the duration of the study.
Detailed description
Obesity is a multifactorial, chronic, and progressive disease of pandemic proportions. Incretin mimetics , such as semaglutide and tirzepatide, induce weight loss in adults with obesity, while also improving weight-related medical conditions, such as cardiac and renal disease. The beneficial effects on weight and metabolism require the continued presence of these medications, which have a half-life of approximately five to seven days. This concept was substantially illustrated in the STEP4 and SURMOUNT4 randomized controlled trials. In the STEP4 trial, adults with obesity were treated with semaglutide for a 20-week run-in, losing 10.6% of body weight, thereafter randomized 2:1 to continued semaglutide use vs placebo. Over the subsequent 48 weeks, the semaglutide arm lost an additional 7.9% of original body weight, whereas the placebo arm saw two-thirds the lost weight return. In the SURMOUNT-4 trial, adults with obesity were treated with tirzepatide for a 36-week run-in period, losing 20.9% of body weight, thereafter, randomized 1:1 for continued treatment or placebo. Over the subsequent 52 weeks, the treatment arm lost an additional 5.5% of body weight, whereas the placebo arm saw a return of approximately half the weight that had been lost. These observations present challenges for long-term obesity management when confronted by multiple reports showing high rates of discontinuation of incretin mimetics soon after initiation. These observations present challenges for long-term obesity management when confronted by multiple reports showing high rates of discontinuation of incretin mimetics soon after initiation. Gastric fundal mucosal ablation (GFMA) is a novel endoscopic approach to control appetite which uses hybrid argon plasma coagulation (HybridAPC) to ablate the superficial tissue of the gastric fundus to induce cell death and fibrotic remodeling. In an early safety and feasibility study of ten adults with obesity, GFMA reduced circulating levels of the only known hunger hormone in humans, ghrelin. This led to a measured suppression of inter-meal hunger and cravings, as well as improved confidence in the ability to resist cravings. In addition to reducing ghrelin-producing cell population within the fundus, GFMA induced significant fundal fibrin deposition. This resulted in a stiffer, less compliant fundus, reducing maximum tolerated volume of a standardized nutrient drink test, enhancing intra-meal satiation. Given that GFMA induces appetite control through both visceroceptive and hormonal mechanism, much like incretin mimetics, we hypothesize that GFMA can prevent or limit weight recurrence in adults who have stopped these medications after successful obesity treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy | Experimental | Device: Gastric Fundal Mucosal Ablation (GFMA)Subjects will undergo endoscopic Gastric Fundal Mucosal Ablation (GFMA) following following discontinuation of GLP-1 therapy. This will be performed by an experienced endoscopist specialized in bariatric endoscopy in a single endoscopic session. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects aged 21-65
- Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤45 kg/m²
- Observed ≥ 10% TBWL with semaglutide or tirzepatide use for primary obesity therapy
- Subject did not experience >50% weight recurrence since discontinuation of semaglutide or tirzepatide
- Maintained a stable dose of semaglutide or tirzepatide for a minimum of 12 weeks
Key exclusion criteria (16 listed)
- Known diagnosis of type I or type II diabetes or a Hemoglobin A1c > 6.5% at time of screening
- Use of GLP-1 or GLP-1/GIP medication for the treatment of diabetes, rather than obesity.
- Use of anticoagulation, antithrombotic agents, and/or NSAIDs that cannot be discontinued for a minimum of 12 weeks
- Known bleeding diathesis that cannot be corrected through medical means.
- History of decompensated end-organ disease
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 |
|---|---|---|
| Gastric Fundal Mucosal Ablation (GFMA)Endoscopic Gastric Fundal Mucosal Ablation (GFMA) after discontinuation of GLP-1 therapy | Device | Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy |
Primary outcome
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Time frame: 12 months
Measure percent change in total body weight over time following endoscopic GFMA. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
9 secondary outcomes
Rate of Adverse Events (AE)
Time frame: Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
Quality of Life Assessment
Time frame: 1 Month, 2 Months, 3 Months, 6 Months, 12 Months
Quality of Life Assessment
Time frame: 1 Month, 2 Months, 3 Months, 6 Months, 12 Months
Appetite and Hunger Assessment
Time frame: Month 1, Month 2, Month 3, Month 6, Month 12
Percent Change in Total Body Weight Loss (TBWL) from Baseline
Time frame: Month 1, Month 3, Month 6, Month 9
Change in Body Mass Index (BMI) from Baseline
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Percent Weight Recurrence from Baseline
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12
Measured Proportion of Patients with weight recurrence
Time frame: 6 Months, 12 Months
Eating Behavior and Weight Management Self-Efficacy Assessment
Time frame: Month 1, Month 2, Month 3, Month 6, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 29476845Kumbhari V, Lehmann S, Schlichting N, Heinrich M, Kullnick Y, Retschlag U, Enderle M, Dietrich A, Khashab MA, Kalloo AN, Oberbach A. Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model. Gastrointest Endosc. 2018 Jul;88(1):175-184.e1. doi: 10.1016/j.gie.2018.02.022. Epub 2018 Feb 22.
- Background: PubMed 35441470Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.
- Background: PubMed 37445623Popoviciu MS, Paduraru L, Yahya G, Metwally K, Cavalu S. Emerging Role of GLP-1 Agonists in Obesity: A Comprehensive Review of Randomised Controlled Trials. Int J Mol Sci. 2023 Jun 21;24(13):10449. doi: 10.3390/ijms241310449.
- Individual participant dataSharing planned: Undecided
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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.
Christopher McGowan, MD, MSCR principal investigator
True You Weight Loss
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Fundal Mucosal Ablation (GFMA) in people with Obesity and Obesity-related Medical Conditions and Obesity and Overweight, run by Dr. Christopher McGowan at 2 sites 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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon Casey, MS ((919) 391-7843, Shannon@trueyouweightloss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Total Body Weight Loss (TBWL) from Baseline (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06734312, which also lists 3 linked publications.
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 21 Mar 2025.