Metabolism DisorderMELTNCT06899958
Metabolism Enhancement by Laser Therapy
A study testing Fractional Laser in people with Metabolism Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a single-center, open-label pilot study to determine the effect of large area fractional laser treatment (LAFLT) on adults' metabolic profile. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism Disorder
- What is being tested?
- Fractional Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2029
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18- 60 years of age;
- BMI between 25.0 and 30 kg/m2;
- Subjects must be in good general health, based on answers provided during the screening visit;
- Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol.
- Females of childbearing potential must be willing and able to use a medically highly effective form of birth control during the entire study.
Who cannot join
- Participation in another investigational drug or device clinical trial in the past 30 days;
- Currently pregnant or pregnancy within the past 6 months or currently breastfeeding;
- Have a history of drug or alcohol abuse in the past 3 years or have reported habitual alcohol intake greater than 2 standard drinks per day (e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks);
- Planning or currently participating in a weight loss program;
- Plan to change daily diet or level of physical activity;
- Intake of medication that may affect body weight such as GLP-1 receptor agonists, amitriptyline, bupropion, thyroid medications, etc.;
Show all 21Show fewer
- History of cancer which required lymph node biopsy or dissection;
- Weight loss or gain of 10 kg or more in the past 6 months;
- History of diabetes mellitus or cardiac disease;
- Intake of hormone replacement therapy (HRT) in the last 6 months;
- Infection, surgery, or history of trauma or laser treatment to the treatment area in the past 6 months;
- Presence of any skin disease on the abdomen or thighs;
- Have birthmarks, tattoos, scars, or any other disfiguration of the skin in the abdomen or thighs;
- Presence of sunburn or tan in the abdomen or thighs;
- Use of any topical application of retinoids in the past 6 weeks on the abdomen or thighs or intake of systemic retinoids in the past 6 months;
- Use of any prescription topical medication, such as corticosteroids or hydroquinone on the abdomen or thighs in the past 6 weeks;
- History of keloid formation or hypertrophic scarring;
- History of bariatric surgery or other major weight-loss procedures;
- History of abdominal liposuction, abdominoplasty or CoolSculpting;
- Known allergy to lidocaine or other local anesthetics;
- The investigator believes that the subject is an unsuitable candidate to participate in the study, receive laser treatment, or would be placed at risk by participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MGH Clinical Unit for Research Trials & Outcomes in Skin
Boston, Massachusetts, 02114
Alicia Van Cott, NP, 617-726-4454, avancott@mgb.org
About this study
This is a single-center, open-label pilot study to determine the effect of large area fractional laser treatment (LAFLT) on adults' metabolic profile.
Read the detailed description
The current research project aims to investigate the effects of large-area fractional laser treatment (LAFLT) on body weight, metabolism, and body composition. Prior research suggests that treating large skin areas with fractional laser therapy may stimulate metabolism and promote weight loss. The MIRIA laser, an FDA-approved fractional laser, is widely used for skin aging, acne scarring, and wrinkle reduction and will be used to evaluate these potential metabolic effects.
Subjects aged 18-60 with a BMI of 25-30 will undergo three fractional laser treatments on the abdomen and thighs over 36 weeks, with sessions every four weeks. The study includes six total visits, incorporating photography, non-invasive imaging, x-rays, blood draws, and two optional biopsies.
- Conditions
- Metabolism Disorder
- Being tested
- Fractional Laser
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional LaserDevice
Three fractional laser treatments to the abdomen and thighs at 4 week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Fractional Laser treatment | Experimental | Large Area Fractional Laser treatments to the abdomen and thighs using the MIRIA laser. Receives: Device: Fractional Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Body Fat (%)
The percent body fat will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA).
Measured: Week 1, 12, 24
Body Mass Index (BMI) (kg/m²)
BMI will be calculated using the formula: weight (kg) / [height (m)]². Height will be measured at the baseline visit and body weight will be measured at each of the following visits.
Measured: Week 0, 4, 8, 12, 24
Waist circumference (cm)
These measurements will be taken at each of the following visits
Measured: Week 0, 4, 8, 12, 24
Hip circumference (cm)
These measurements will be taken at each of the following visits
Measured: Week 0, 4, 8, 12, 24
Arm circumference (cm)
These measurements will be taken at each of the following visits
Measured: Week 0, 4, 8, 12, 24
Total Lean Body Mass (kg)
The total lean body mass will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA).
Measured: Week 1, 12, 24
Secondary outcomes (19)
Complete Blood Count (CBC)
Measurement of red blood cell count, white blood cell count, hemoglobin, hematocrit, and platelet count via a blood draw.
Measured: Week 0, 4, 8, 12, 24
Comprehensive Metabolic Panel (CMP)
Assessment of glucose, calcium, electrolyte and fluid balance (sodium, potassium, CO2, chloride), kidney function (BUN, creatinine), and liver function (albumin, total protein, ALP, ALT, AST, bilirubin) via a blood draw.
Measured: Week 0, 4, 8, 12, 24
Lipid Panel
Measurement of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides via a blood draw.
Measured: Week 0, 4, 8, 12, 24
HbA1c
Measurement of hemoglobin A1c via a blood draw.
Measured: Week 0, 4, 8, 12, 24
C-Reactive Protein (CRP)
Measurement of CRP levels via a blood draw.
Measured: Week 0, 4, 8, 12, 24
Erythrocyte Sedimentation Rate (ESR)
Assessment of the rate at which red blood cells sediment via a blood draw.
Measured: Week 0, 4, 8, 12, 24
Histamine
Measurement of plasma histamine levels via a blood draw.
Measured: Week 0, 4, 8, 12, 24
Cortisol
Measurement of serum cortisol levels via a blood draw.
Measured: Week 0, 4, 8, 12, 24
Oxytocin
Measurement of serum oxytocin levels via a blood draw.
Measured: Week 0, 4, 8, 12, 24
Creatine Phosphokinase (CPK)
Measurement of serum CPK via a blood draw.
Measured: Week 0, 4, 8, 12, 24
Serum Interleukin-6 (IL-6)
Measurement of interleukin-6 (IL-6) via a blood draw.
Measured: Week 0, 4, 8, 12, 24
Serum Norepinephrine
Measurement of norepinephrine via a blood draw.
Measured: Week 0, 4, 8, 12, 24
Indirect Calorimetry
This is a non-invasive procedure that measures how much energy the body uses.
Measured: Week 0,12, 24
Skin Biopsy (Optional)
2 optional biopsies will be take pre- and post-laser treatment to measure changes in collagen and skin thickness.
Measured: Week 1, 12
Skin Elasticity
Ultrasound will be used to measure skin elasticity.
Measured: Week 0, 4, 8, 12, 24
Skin Thickness
Ultrasound will be used to measure skin thickness.
Measured: Week 0, 4, 8, 12, 24
Hydration Status (%)
Estimation of total body water content as a percentage of body weight using the Bioelectrical impedance analysis (BIA).
Measured: Week 0, 12
VAS Pain Score
The visual analog scale (VAS) pain score will be collected from the subject after each laser treatment. The VAS is a 10cm long scale with 0cm representing "no pain" and 10cm representing "worst possible pain".
Measured: Week 1, 4, 8
Total Body Bone Mineral Density (g/cm²)
The total body BMD will be collected from the Dual energy x-ray absorptiometry scan (DEXA).
Measured: Week 1, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Jan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Metabolism DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Alora, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899958
- Sponsor's protocol ID
- 2025P000547
- Acronym
- MELT
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Salma N, Wang-Evers M, Karasik D, Yerevanian A, Downs H, Luo T, Doyle AE, Tannous Z, Cacicedo JM, Manstein D. Large area fractional laser treatment of mouse skin increases energy expenditure. iScience. 2023 Dec 7;27(1):108677. doi: 10.1016/j.isci.2023.108677. eCollection 2024 Jan 19.
PubMed 38213618May M, Schindler C, Engeli S. Modern pharmacological treatment of obese patients. Ther Adv Endocrinol Metab. 2020 Jan 22;11:2042018819897527. doi: 10.1177/2042018819897527. eCollection 2020.
PubMed 32030121Singh G, Krauthamer M, Bjalme-Evans M. Wegovy (semaglutide): a new weight loss drug for chronic weight management. J Investig Med. 2022 Jan;70(1):5-13. doi: 10.1136/jim-2021-001952. Epub 2021 Oct 27.
PubMed 34706925Bettini S, Belligoli A, Fabris R, Busetto L. Diet approach before and after bariatric surgery. Rev Endocr Metab Disord. 2020 Sep;21(3):297-306. doi: 10.1007/s11154-020-09571-8.
PubMed 32734395Patsouris D, Qi P, Abdullahi A, Stanojcic M, Chen P, Parousis A, Amini-Nik S, Jeschke MG. Burn Induces Browning of the Subcutaneous White Adipose Tissue in Mice and Humans. Cell Rep. 2015 Nov 24;13(8):1538-44. doi: 10.1016/j.celrep.2015.10.028. Epub 2015 Nov 12.
PubMed 26586436Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
PubMed 15216537Laubach HJ, Tannous Z, Anderson RR, Manstein D. Skin responses to fractional photothermolysis. Lasers Surg Med. 2006 Feb;38(2):142-9. doi: 10.1002/lsm.20254.
PubMed 16392146Gotkin RH, Sarnoff DS, Cannarozzo G, Sadick NS, Alexiades-Armenakas M. Ablative skin resurfacing with a novel microablative CO2 laser. J Drugs Dermatol. 2009 Feb;8(2):138-44.
PubMed 19213229Prignano F, Ricceri F, Bonan P, Cannarozzo G, Campolmi P. Induction of apoptosis by fractional CO2 laser treatment. J Cosmet Laser Ther. 2012 Dec;14(6):267-71. doi: 10.3109/14764172.2012.738820.
PubMed 23058108Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8.
PubMed 19787413Porter C, Tompkins RG, Finnerty CC, Sidossis LS, Suman OE, Herndon DN. The metabolic stress response to burn trauma: current understanding and therapies. Lancet. 2016 Oct 1;388(10052):1417-1426. doi: 10.1016/S0140-6736(16)31469-6.
PubMed 27707498Knuth CM, Auger C, Jeschke MG. Burn-induced hypermetabolism and skeletal muscle dysfunction. Am J Physiol Cell Physiol. 2021 Jul 1;321(1):C58-C71. doi: 10.1152/ajpcell.00106.2021. Epub 2021 Apr 28.
PubMed 33909503Jeschke MG. The hepatic response to thermal injury: is the liver important for postburn outcomes? Mol Med. 2009 Sep-Oct;15(9-10):337-51. doi: 10.2119/molmed.2009.00005. Epub 2009 Apr 10.
PubMed 19603107Hew JJ, Parungao RJ, Shi H, Tsai KH, Kim S, Ma D, Malcolm J, Li Z, Maitz PK, Wang Y. Mouse models in burns research: Characterisation of the hypermetabolic response to burn injury. Burns. 2020 May;46(3):663-674. doi: 10.1016/j.burns.2019.09.014. Epub 2019 Oct 10.
PubMed 31606314Jeschke MG, van Baar ME, Choudhry MA, Chung KK, Gibran NS, Logsetty S. Burn injury. Nat Rev Dis Primers. 2020 Feb 13;6(1):11. doi: 10.1038/s41572-020-0145-5.
PubMed 32054846
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism Enhancement by Laser Therapy
- ClinicalTrials.gov ID
- NCT06899958
- Acronym / sponsor ID
- MELT / 2025P000547
- Conditions
- Metabolism Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Mar 2025 (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.
This is a single-center, open-label pilot study to determine the effect of large area fractional laser treatment (LAFLT) on adults' metabolic profile.
Detailed description
The current research project aims to investigate the effects of large-area fractional laser treatment (LAFLT) on body weight, metabolism, and body composition. Prior research suggests that treating large skin areas with fractional laser therapy may stimulate metabolism and promote weight loss. The MIRIA laser, an FDA-approved fractional laser, is widely used for skin aging, acne scarring, and wrinkle reduction and will be used to evaluate these potential metabolic effects.
Subjects aged 18-60 with a BMI of 25-30 will undergo three fractional laser treatments on the abdomen and thighs over 36 weeks, with sessions every four weeks. The study includes six total visits, incorporating photography, non-invasive imaging, x-rays, blood draws, and two optional biopsies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional Laser treatment | Experimental | Device: Fractional LaserLarge Area Fractional Laser treatments to the abdomen and thighs using the MIRIA laser. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18- 60 years of age;
- BMI between 25.0 and 30 kg/m2;
- Subjects must be in good general health, based on answers provided during the screening visit;
- Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol.
- Females of childbearing potential must be willing and able to use a medically highly effective form of birth control during the entire study.
Key exclusion criteria (21 listed)
- Participation in another investigational drug or device clinical trial in the past 30 days;
- Currently pregnant or pregnancy within the past 6 months or currently breastfeeding;
- Have a history of drug or alcohol abuse in the past 3 years or have reported habitual alcohol intake greater than 2 standard drinks per day (e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks);
- Planning or currently participating in a weight loss program;
- Plan to change daily diet or level of physical activity;
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 |
|---|---|---|
| Fractional LaserThree fractional laser treatments to the abdomen and thighs at 4 week intervals. | Device | Fractional Laser treatment |
Primary outcome
Percent Body Fat (%)
Time frame: Week 1, 12, 24
The percent body fat will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA).
Body Mass Index (BMI) (kg/m²)
Time frame: Week 0, 4, 8, 12, 24
BMI will be calculated using the formula: weight (kg) / [height (m)]². Height will be measured at the baseline visit and body weight will be measured at each of the following visits.
Waist circumference (cm)
Time frame: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Hip circumference (cm)
Time frame: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Arm circumference (cm)
Time frame: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Total Lean Body Mass (kg)
Time frame: Week 1, 12, 24
The total lean body mass will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA).
19 secondary outcomes
Complete Blood Count (CBC)
Time frame: Week 0, 4, 8, 12, 24
Comprehensive Metabolic Panel (CMP)
Time frame: Week 0, 4, 8, 12, 24
Lipid Panel
Time frame: Week 0, 4, 8, 12, 24
HbA1c
Time frame: Week 0, 4, 8, 12, 24
C-Reactive Protein (CRP)
Time frame: Week 0, 4, 8, 12, 24
Erythrocyte Sedimentation Rate (ESR)
Time frame: Week 0, 4, 8, 12, 24
Histamine
Time frame: Week 0, 4, 8, 12, 24
Cortisol
Time frame: Week 0, 4, 8, 12, 24
Oxytocin
Time frame: Week 0, 4, 8, 12, 24
Creatine Phosphokinase (CPK)
Time frame: Week 0, 4, 8, 12, 24
Serum Interleukin-6 (IL-6)
Time frame: Week 0, 4, 8, 12, 24
Serum Norepinephrine
Time frame: Week 0, 4, 8, 12, 24
Indirect Calorimetry
Time frame: Week 0,12, 24
Skin Biopsy (Optional)
Time frame: Week 1, 12
Skin Elasticity
Time frame: Week 0, 4, 8, 12, 24
Skin Thickness
Time frame: Week 0, 4, 8, 12, 24
Hydration Status (%)
Time frame: Week 0, 12
VAS Pain Score
Time frame: Week 1, 4, 8
Total Body Bone Mineral Density (g/cm²)
Time frame: Week 1, 12, 24
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 11 Feb 2026.
- Background: PubMed 38213618Salma N, Wang-Evers M, Karasik D, Yerevanian A, Downs H, Luo T, Doyle AE, Tannous Z, Cacicedo JM, Manstein D. Large area fractional laser treatment of mouse skin increases energy expenditure. iScience. 2023 Dec 7;27(1):108677. doi: 10.1016/j.isci.2023.108677. eCollection 2024 Jan 19.
- Background: PubMed 32030121May M, Schindler C, Engeli S. Modern pharmacological treatment of obese patients. Ther Adv Endocrinol Metab. 2020 Jan 22;11:2042018819897527. doi: 10.1177/2042018819897527. eCollection 2020.
- Background: PubMed 34706925Singh G, Krauthamer M, Bjalme-Evans M. Wegovy (semaglutide): a new weight loss drug for chronic weight management. J Investig Med. 2022 Jan;70(1):5-13. doi: 10.1136/jim-2021-001952. Epub 2021 Oct 27.
- Background: PubMed 32734395Bettini S, Belligoli A, Fabris R, Busetto L. Diet approach before and after bariatric surgery. Rev Endocr Metab Disord. 2020 Sep;21(3):297-306. doi: 10.1007/s11154-020-09571-8.
- Background: PubMed 26586436Patsouris D, Qi P, Abdullahi A, Stanojcic M, Chen P, Parousis A, Amini-Nik S, Jeschke MG. Burn Induces Browning of the Subcutaneous White Adipose Tissue in Mice and Humans. Cell Rep. 2015 Nov 24;13(8):1538-44. doi: 10.1016/j.celrep.2015.10.028. Epub 2015 Nov 12.
- Background: PubMed 15216537Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
- Background: PubMed 16392146Laubach HJ, Tannous Z, Anderson RR, Manstein D. Skin responses to fractional photothermolysis. Lasers Surg Med. 2006 Feb;38(2):142-9. doi: 10.1002/lsm.20254.
- Background: PubMed 19213229Gotkin RH, Sarnoff DS, Cannarozzo G, Sadick NS, Alexiades-Armenakas M. Ablative skin resurfacing with a novel microablative CO2 laser. J Drugs Dermatol. 2009 Feb;8(2):138-44.
- Background: PubMed 23058108Prignano F, Ricceri F, Bonan P, Cannarozzo G, Campolmi P. Induction of apoptosis by fractional CO2 laser treatment. J Cosmet Laser Ther. 2012 Dec;14(6):267-71. doi: 10.3109/14764172.2012.738820.
- Background: PubMed 19787413Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8.
- Background: PubMed 27707498Porter C, Tompkins RG, Finnerty CC, Sidossis LS, Suman OE, Herndon DN. The metabolic stress response to burn trauma: current understanding and therapies. Lancet. 2016 Oct 1;388(10052):1417-1426. doi: 10.1016/S0140-6736(16)31469-6.
- Background: PubMed 33909503Knuth CM, Auger C, Jeschke MG. Burn-induced hypermetabolism and skeletal muscle dysfunction. Am J Physiol Cell Physiol. 2021 Jul 1;321(1):C58-C71. doi: 10.1152/ajpcell.00106.2021. Epub 2021 Apr 28.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional Laser in people with Metabolism Disorder, run by Massachusetts General Hospital 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 5 inclusion and 21 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: opening soon, as of the sponsor's last update on 11 Feb 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.
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 Maria Alora, MD (617-726-4454, mansteinlab@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Body Fat (%) (time frame: Week 1, 12, 24). The study lists 6 primary outcomes in all. 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 NCT06899958, which also lists 17 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 11 Feb 2026.