Obesity (Disorder)Phase 4JOULE-MARSNCT06852391
JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity
A Phase 4 study testing Semaglutide Pen Injector and Behavioural Lifestyle Program (BLP) in people with Obesity (Disorder), run by McMaster University at 1 site in Canada.
Trial summary
The Joule MARS study is a single center, randomized, open label clinical trial aiming to explore the metabolic adaptations that occur in response to weight management in adolescents with obesity. Behavioural lifestyle intervention with and without a pharmacological intervention - semaglutide- will be studied. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obesity (Disorder)
- What is being tested?
- Semaglutide Pen Injector and Behavioural Lifestyle Program (BLP)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jun 2025to 31 Dec 2027
- Phase
- Phase 4
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth aged 12-17 years
- Diagnosed with obesity (BMI ≥2 standard deviations above WHO Reference median)
- Enrolled in Growing Health Weight Management or Next Step pediatric clinics (ie. have at least one year of the program remaining).
Who cannot join
- Any contraindications for MRI (i.e. claustrophobia, implanted metal, metallic injuries recent tattoo or weight >300lb. Ineligible for imaging visit only.
- Use of atypical anti-psychotics.
- Use of the following medication classes: (i.e. Beta-blocker medications, Steatogenic medications, Anti-hyperglycemic medications, HIV drugs, Antidepressants, anxiolytic drugs, anti-psychotic drugs, Thyroid drugs, Antiemetic or amphetamine, dextromethorphan and metoclopramide.)
- Elevated alanine aminotransferase (ALT) > 5 x upper range of normal at screening.
- Use of glucose lowering or any anti-obesity medication in the previous 3 months.
- Known monogenic, syndromic or hypothalamic causes of obesity.
Show all 19Show fewer
- Diagnosis of type 1 or 2 diabetes mellitus.
- Prior bariatric surgery or liver transplantation.
- Alcohol intake exceeding 3 drinks per week or reported cannabis use.
- Recent history of cigarette smoking (previous 3 months) - ineligible for imaging only.
- History or family history of multiple endocrine neoplasia 2 or medullary thyroid cancer.
- History of pancreatitis.
- Presence of untreated endocrine disorder.
- History of an eating disorder and / or history of suicidal ideation
- History of a cardiac condition that precludes exercise testing or unable to have exercise testing done in the GHWM pediatric clinic, inability to use a cycle ergometer.
- Participant who does not have a peak power value obtained in the GHWM pediatric clinic
- Female who is pregnant, breast-feeding or intends to become pregnant.
- Female who refuses to use a means of contraception if sexually active.
- Participation in any interventional clinical study within 90 days before screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4L8
Athena Flores Miranda, 905-525-9140 ext. 21407, joulemrs@mcmaster.ca
Aaron Thomas, 905-525-9140 ext. 21407, joulemrs@mcmaster.ca
About this study
Official title: JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity - a Randomized Controlled Trial
The Joule MARS study is a single center, randomized, open label clinical trial aiming to explore the metabolic adaptations that occur in response to weight management in adolescents with obesity. Behavioural lifestyle intervention with and without a pharmacological intervention - semaglutide- will be studied. Study participants will be randomized to one of two groups. Group A will follow a behavioral lifestyle program (BLP) alone for 6 months, followed by BLP and treatment with semaglutide for six months. Group B will be enrolled in BLP and semaglutide from baseline to 6 months. The primary research question will assess, in youth aged 12-17 years diagnosed with obesity and enrolled in a weight management program, if the implementation of a BLP together with semaglutide, compared to the implementation of BLP alone for 6 months leads to less adaptive thermogenesis.
Read the detailed description
The Joule MARS (Metabolic Adaptation to weight loss in Response to a behavioural lifestyle program with or without Semaglutide in adolescents with obesity) study is a single-center, randomized controlled trial designed to investigate the effects of a behaviour lifestyle program and the medication semaglutide on resting energy expenditure (REE), work efficiency during standard exercise on a cycle ergometer and related metabolic outcomes in adolescents with obesity. The study will involve two intervention groups:
Group A will participate in a behavioral lifestyle program (BLP) alone for 6 months followed by a combination of semaglutide treatment and a BLP for an additional 6 months.
Group B will receive semaglutide and a BLP for the first 6 months and then terminate the study.
The study objectives are to determine if, in youth aged 12-17 years with obesity and enrolled in a weight management program:
- the implementation of a BLP and semaglutide, compared to the implementation of a BLP alone leads to less adaptive thermogenesis (AT) at 6 months;
- the implementation of a BLP and semaglutide, compared to the implementation of a BLP alone for 6-month, leads to: Less increase in energy work efficiency during standardized exercise Differences in BAT activity Differences in health-related quality of life (HRQoL)
- BLP and semaglutide, compared to BLP alone, lead to improvements in metabolic health measures (including lipids, glycemia, liver enzymes, hepatic fat and hepatic stiffness) after 6 months.
- A longer time enrolled in BLP prior to addition of 6 months of semaglutide alters health outcome response to semaglutide.
A comprehensive assessment will be conducted throughout the study. Using whole-room indirect calorimetry, REE and muscle work efficiency, evaluated during standardized physical activity on a cycle ergometer, will be measured. Body composition (Dual energy x-ray absorptiometry and bioelectric impedance analysis), anthropometry (height, weight, waist circumference, BMI, BMI z score (WHO)), metabolic health, health related quality of life, hepatic fat and cold induced brown adipose tissue activity (MRI) will be assessed. Randomization will be managed via the REDCap EDC system.
- Conditions
- Obesity (Disorder)
- Being tested
- Semaglutide Pen Injector, Behavioural Lifestyle Program (BLP)
- Keywords
- Adaptive Thermogenesis, obesity, semaglutide, GLP-1 agonist, weight loss, Energy expenditure, Whole room calorimetry, MRI, MR elastography, Cold exposure, Liver stiffness, Brown adipose tissue, Pediatric, Quality of life
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Pen InjectorDrug
Also called Wegovy®
Semaglutide will be delivered by a subcutaneous injection using an injectable pen once weekly. Semaglutide is formulated with 5 approved doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg). Treatment will commence with the lowest dose and will be increased every 4 weeks to the maximum tolerable dose where they will remain for the remainder of the treatment. Participants who are taking the drug will have monthly visits to assess any adverse events, dose titration and drug adherence.
Behavioural Lifestyle Program (BLP)Behavioural
The BLP will be delivered by the Growing Healthy Weight Management (GHWM) pediatric program at McMaster Children's Hospital. GHWM is a family-based program addressing health behaviours (nutritional pattern and eating behaviours, physical activity, sedentary time and sleep) and physical and mental health issues. In Year 1, the program typically includes 2 group sessions and monthly individualized sessions with the participant and their family. The interdisciplinary weight management team is comprised of a registered dietician, exercise physiologist, kinesiologist, social worker and/or psychologist, general pediatrician and pediatric endocrinologists.
| Study group | Role | What they receive |
|---|---|---|
| BLP, then BLP+semaglutide | Active comparator | Group A will engage in a BLP alone for the first six months of the study, then receive BLP and semaglutide (Wegovy®) for the last six months of the study, beginning with 0.25 mg subcutaneously weekly and being titrated every four weeks up to a maximum of 2.4 mg in approved doses 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg. Receives: Drug: Semaglutide Pen Injector; Behavioral: Behavioural Lifestyle Program (BLP) |
| BLP and semaglutide | Experimental | In addition to BLP, Group B will receive semaglutide (Wegovy®) titrated to maximal dose tolerated, in approved doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg subcutaneously weekly for 6 months . Receives: Drug: Semaglutide Pen Injector; Behavioral: Behavioural Lifestyle Program (BLP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Adaptive thermogenesis
Adaptive thermogenesis will be calculated as the difference between measured and predicted REE after the intervention. Measured REE will be assessed with the participant awake, but at rest, in a whole room indirect calorimeter. Predicted REE will be calculated based on an equation derived using baseline data from this study population as is currently recommended. Variables that will be considered in deriving the equation include fat-free mass, fat mass, age and sex. We will compare adaptive thermogenesis (primary outcome) and work efficiency between the two treatments utilizing linear regression analysis. Separate analyses for males and females will ensure relevance of study findings to both sexes.
Measured: 6, 12 months
Secondary outcomes (10)
Changes in energy work efficiency from baseline during standardized exercise
Energy work efficiency will be measured by measuring the physical activity energy expenditure (PAEE) from cycle ergometry using whole room calorimetry. This will be calculated as follows: Net mechanical efficiency (mechanical efficiency above resting): Ratio of power generated (kcal/min) / (PA EE - REE). One kcal/hour = 1.163 W Thus, [Power (W) x 0.01433 (kcal/min) / (PA EE (kcal/min) - resEE (kcal/min))] x100 = Work efficiency (%)
Measured: Baseline, 6, 12 months
Brown Adipose Tissue (BAT) activity
Relative decline in supraclavicular fat proton density fat fraction after cold exposure as previously published (Ahmed et al., 2021)
Measured: From enrollment to 6 months and to 12 months
Health-related quality of life (HRQoL)
This will be measured using the Impact of Weight on Quality of Life kids (IWQOL-kids) questionnaire. Score ranges from 0 to 100, with 100 representing the best quality of life. In addition to a total score, there are scores on four domains:
Physical Comfort (6 items)
Body Esteem (9 items)
Social life (6 items)
Family Relations (6 items)
Measured: Baseline to 6 months and to 12 months
Total body mass, fat mass and lean mass
Body composition will be preferentially measured using Dual-energy X-ray absorptiometry (DXA) scans (Lunar PRODIGY Advance 8743; GE, Healthcare, Waukesha, WI). If the participant has a weight exceeding the limits for the machine, Bioelectrical Impedance Analysis (BIA) (InBody 570) will be utilized.
Measured: Baseline, 6, 12 months
Hepatic fat content
Hepatic fat content will be measured via MRI conducted by a technician at St. Joseph's hospital at baseline, 6 months and 12 months using standardized techniques for precision, accuracy and determination of proton density fat fraction (PDFF) quantification of the whole liver
Measured: Baseline, 6, 12 months
Hepatic stiffness
Hepatic stiffness, an indicator of hepatic fibrosis, will be measured via Magnetic resonance elastography (MRE) using standardized techniques for precision and accuracy.
Measured: Baseline, 6 and 12 months
Fasting lipid profile
Differences in fasting lipids will be collected via fasting bloodwork. The types of lipids that will be collected will be triglycerides, cholesterol, High-density lipoprotein (HDL) and Low-density lipoprotein (LDL) (mmol/L).
Measured: Baseline, 6, 12 months
Fasting insulin
Fasting insulin will be measured with bloodwork collected. HOMA-IR will be calculated to determine insulin resistance
Measured: Baseline, 6, 12 months
Hemoglobin A1C
Hemoglobin A1C to be measured in laboratory at Hamilton Health Sciences
Measured: Baseline, 6 and 12 months
Alanine aminotransferase
ALT will be measured in the laboratory at Hamilton Health Sciences
Measured: Baseline, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start18 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Diabetes Canada
- Responsible party
- Sponsor
- Investigators
- Katherine M Morrison, MD FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852391
- Sponsor's protocol ID
- 18026
- Acronym
- JOULE-MARS
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06852391
- Acronym / sponsor ID
- JOULE-MARS / 18026
- Conditions
- Obesity (Disorder)
- Keywords
- Adaptive Thermogenesis, obesity, semaglutide, GLP-1 agonist, weight loss, Energy expenditure, Whole room calorimetry, MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Diabetes Canada
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Feb 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.
The Joule MARS study is a single center, randomized, open label clinical trial aiming to explore the metabolic adaptations that occur in response to weight management in adolescents with obesity. Behavioural lifestyle intervention with and without a pharmacological intervention - semaglutide- will be studied. Study participants will be randomized to one of two groups. Group A will follow a behavioral lifestyle program (BLP) alone for 6 months, followed by BLP and treatment with semaglutide for six months. Group B will be enrolled in BLP and semaglutide from baseline to 6 months. The primary research question will assess, in youth aged 12-17 years diagnosed with obesity and enrolled in a weight management program, if the implementation of a BLP together with semaglutide, compared to the implementation of BLP alone for 6 months leads to less adaptive thermogenesis.
Detailed description
The Joule MARS (Metabolic Adaptation to weight loss in Response to a behavioural lifestyle program with or without Semaglutide in adolescents with obesity) study is a single-center, randomized controlled trial designed to investigate the effects of a behaviour lifestyle program and the medication semaglutide on resting energy expenditure (REE), work efficiency during standard exercise on a cycle ergometer and related metabolic outcomes in adolescents with obesity. The study will involve two intervention groups:
Group A will participate in a behavioral lifestyle program (BLP) alone for 6 months followed by a combination of semaglutide treatment and a BLP for an additional 6 months.
Group B will receive semaglutide and a BLP for the first 6 months and then terminate the study.
The study objectives are to determine if, in youth aged 12-17 years with obesity and enrolled in a weight management program:
- the implementation of a BLP and semaglutide, compared to the implementation of a BLP alone leads to less adaptive thermogenesis (AT) at 6 months;
- the implementation of a BLP and semaglutide, compared to the implementation of a BLP alone for 6-month, leads to: Less increase in energy work efficiency during standardized exercise Differences in BAT activity Differences in health-related quality of life (HRQoL)
- BLP and semaglutide, compared to BLP alone, lead to improvements in metabolic health measures (including lipids, glycemia, liver enzymes, hepatic fat and hepatic stiffness) after 6 months.
- A longer time enrolled in BLP prior to addition of 6 months of semaglutide alters health outcome response to semaglutide.
A comprehensive assessment will be conducted throughout the study. Using whole-room indirect calorimetry, REE and muscle work efficiency, evaluated during standardized physical activity on a cycle ergometer, will be measured. Body composition (Dual energy x-ray absorptiometry and bioelectric impedance analysis), anthropometry (height, weight, waist circumference, BMI, BMI z score (WHO)), metabolic health, health related quality of life, hepatic fat and cold induced brown adipose tissue activity (MRI) will be assessed. Randomization will be managed via the REDCap EDC system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLP, then BLP+semaglutide | Active comparator | Drug: Semaglutide Pen Injector, Behavioral: Behavioural Lifestyle Program (BLP)Group A will engage in a BLP alone for the first six months of the study, then receive BLP and semaglutide (Wegovy®) for the last six months of the study, beginning with 0.25 mg subcutaneously weekly and being titrated every four weeks up to a maximum of 2.4 mg in approved doses 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg. |
| BLP and semaglutide | Experimental | Drug: Semaglutide Pen Injector, Behavioral: Behavioural Lifestyle Program (BLP)In addition to BLP, Group B will receive semaglutide (Wegovy®) titrated to maximal dose tolerated, in approved doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg subcutaneously weekly for 6 months . |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Youth aged 12-17 years
- Diagnosed with obesity (BMI ≥2 standard deviations above WHO Reference median)
- Enrolled in Growing Health Weight Management or Next Step pediatric clinics (ie. have at least one year of the program remaining).
Key exclusion criteria (19 listed)
- Any contraindications for MRI (i.e. claustrophobia, implanted metal, metallic injuries recent tattoo or weight >300lb. Ineligible for imaging visit only.
- Use of atypical anti-psychotics.
- Use of the following medication classes: (i.e. Beta-blocker medications, Steatogenic medications, Anti-hyperglycemic medications, HIV drugs, Antidepressants, anxiolytic drugs, anti-psychotic drugs, Thyroid drugs, Antiemetic or amphetamine, dextromethorphan and metoclopramide.)
- Elevated alanine aminotransferase (ALT) > 5 x upper range of normal at screening.
- Use of glucose lowering or any anti-obesity medication in the previous 3 months.
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 |
|---|---|---|
| Semaglutide Pen InjectorAlso: Wegovy®Semaglutide will be delivered by a subcutaneous injection using an injectable pen once weekly. Semaglutide is formulated with 5 approved doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg). Treatment will commence with the lowest dose and will be increased every 4 weeks to the maximum tolerable dose where they will remain for the remainder of the treatment. Participants who are taking the drug will have monthly visits to assess any adverse events, dose titration and drug adherence. | Drug | BLP and semaglutide, BLP, then BLP+semaglutide |
| Behavioural Lifestyle Program (BLP)The BLP will be delivered by the Growing Healthy Weight Management (GHWM) pediatric program at McMaster Children's Hospital. GHWM is a family-based program addressing health behaviours (nutritional pattern and eating behaviours, physical activity, sedentary time and sleep) and physical and mental health issues. In Year 1, the program typically includes 2 group sessions and monthly individualized sessions with the participant and their family. The interdisciplinary weight management team is comprised of a registered dietician, exercise physiologist, kinesiologist, social worker and/or psychologist, general pediatrician and pediatric endocrinologists. | Behavioural | BLP and semaglutide, BLP, then BLP+semaglutide |
Primary outcome
Measurement of Adaptive thermogenesis
Time frame: 6, 12 months
Adaptive thermogenesis will be calculated as the difference between measured and predicted REE after the intervention. Measured REE will be assessed with the participant awake, but at rest, in a whole room indirect calorimeter. Predicted REE will be calculated based on an equation derived using baseline data from this study population as is currently recommended. Variables that will be considered in deriving the equation include fat-free mass, fat mass, age and sex. We will compare adaptive thermogenesis (primary outcome) and work efficiency between the two treatments utilizing linear regression analysis. Separate analyses for males and females will ensure relevance of study findings to both sexes.
10 secondary outcomes
Changes in energy work efficiency from baseline during standardized exercise
Time frame: Baseline, 6, 12 months
Brown Adipose Tissue (BAT) activity
Time frame: From enrollment to 6 months and to 12 months
Health-related quality of life (HRQoL)
Time frame: Baseline to 6 months and to 12 months
Total body mass, fat mass and lean mass
Time frame: Baseline, 6, 12 months
Hepatic fat content
Time frame: Baseline, 6, 12 months
Hepatic stiffness
Time frame: Baseline, 6 and 12 months
Fasting lipid profile
Time frame: Baseline, 6, 12 months
Fasting insulin
Time frame: Baseline, 6, 12 months
Hemoglobin A1C
Time frame: Baseline, 6 and 12 months
Alanine aminotransferase
Time frame: Baseline, 3, 6, 9 and 12 months
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 14 Jan 2026.
- 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.
Katherine M Morrison, MD FRCPC principal investigator
McMaster University
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 Semaglutide Pen Injector and Behavioural Lifestyle Program (BLP) in people with Obesity (Disorder), run by McMaster University at 1 site in Canada.
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 3 inclusion and 19 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 14 Jan 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 Canada. 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?
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 Athena Flores Miranda (905-525-9140 ext. 21407, joulemrs@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Adaptive thermogenesis (time frame: 6, 12 months). 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 14 Jan 2026.