Sarcopenic ObesitySarcopeniaNCT07797140
The Effect of Acupuncture on Sarcopenia and Obesity in Patients With Sarcopenic Obesity.
A study testing Diet and exercise and Acupuncture in people with Sarcopenic Obesity and Acupuncture Treatment, run by Ayşe Ukbe Baykut at 1 site in Turkey (Türkiye).
Trial summary
Sarcopenia is defined by the European Working Group on Sarcopenia in Older People (EWGSOP) as "a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, carrying a risk of adverse outcomes such as physical disability, fractures, falls, impaired quality of life, and death. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcopenic Obesity, Acupuncture Treatment, Exercise
- What is being tested?
- Diet and exercise and Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 25 Sep 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having the mental and physical capacity to adapt to the work process
- Being between 18-75 years of age
- Being able to ambulate independently or with support
- Having a body mass index (BMI) ≥ 30 kg/m2
Who cannot join
- Pregnancy
- Infection
- Pacemaker
- Peripheral circulatory disorder
- Known concomitant malignancy, end-stage organ failure
- Known concomitant central nervous system and/or peripheral nervous system disease
Show all 9Show fewer
- History of genetic disease
- Coagulopathy
- Having received acupuncture within the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, çankaya, 06800
About this study
Sarcopenia is defined by the European Working Group on Sarcopenia in Older People (EWGSOP) as "a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, carrying a risk of adverse outcomes such as physical disability, fractures, falls, impaired quality of life, and death. Obesity is classified according to the Body Mass Index (BMI), which is calculated by dividing weight in kilograms by the square of height in meters. According to the World Health Organization and most current guidelines for Western societies, obesity is defined as a BMI ≥ 30 kg/m². Sarcopenic obesity was first defined by Baumgartner as the co-occurrence of sarcopenia and obesity, measured using DEXA (10). Sarcopenic obesity is defined as the co-occurrence of high adiposity and sarcopenia; a term originally coined to describe low skeletal muscle mass, strength, and physical function, initially diagnosed in the elderly but present across the entire age spectrum. Combining the effects of both sarcopenia and obesity, sarcopenic obesity has been found to be associated with lower quality of life and greater disability, morbidity, and mortality compared to obesity or sarcopenia alone. Acupuncture is derived from the Latin words for needle (acus) and piercing (punctura). In Western languages, it is written as acupuncture. In traditional Chinese medicine, it is believed that diseases are caused by disturbances in the flow of life energy (Qi) circulating in channels called meridians in the body. Acupuncture aims to correct this disrupted energy flow by inserting needles into specific points along the meridians in the body. Numerous studies have reported that acupuncture is widely used in the treatment of obesity. Current evidence-based reviews have shown that acupuncture is effective in treating obesity. It has been suggested that acupuncture is an effective treatment for simple obesity rather than a placebo effect.
The literature contains many studies on acupuncture in the treatment of obesity. However, there are no studies on acupuncture in sarcopenic obesity. Our study aimed to determine the effect of acupuncture on sarcopenia and obesity in patients with sarcopenic obesity.
Read the detailed description
Sarcopenic obesity was first defined by Baumgartner as the co-occurrence of sarcopenia and obesity, measured using DEXA (dual-energy x-ray absorptiometry). It is characterized by the simultaneous occurrence of high adiposity and sarcopenia; the term was initially coined to describe low skeletal muscle mass, strength, and physical function, initially diagnosed in the elderly but present across the entire age spectrum. Combining the effects of both sarcopenia and obesity, sarcopenic obesity has been associated with a lower quality of life and greater disability, morbidity, and mortality compared to obesity or sarcopenia alone. The lack of accurate prevalence rates for sarcopenic obesity stems from the absence of a consistent definition for sarcopenia or obesity. In a population-based cohort using National Health and Nutrition Examination Survey (NHANES) data applying FNIH criteria, sarcopenic obesity rates were found to be 12.6% in men and 33.5% in women, and these rates increased with age, reaching 27.5% in men and 48% in women over 80 years of age. The pathogenesis of sarcopenic obesity is multifactorial; the interaction between aging, sedentary lifestyle, unhealthy dietary habits, and insulin resistance, systemic inflammation, and oxidative stress leads to a quantitative and qualitative decrease in muscle mass and function, and a parallel increase in fat mass. Common etiological factors affect both muscle and fat mass. Current definitions of sarcopenic obesity are based on individual definitions of sarcopenia and obesity, but there is currently no consensus defining cut-off values for either of these conditions, making it difficult to reach an accurate diagnosis of sarcopenic obesity. In sarcopenic obesity, anthropometric measurements (weight, BMI, waist circumference) are normal or high, and imaging (DEXA, BIA, CT, MRI) shows high fat mass and low muscle mass. Acupuncture is derived from the Latin words for needle (acus) and piercing (punctura). In Western languages, it is written as acupuncture. In traditional Chinese medicine, it is believed that diseases are caused by disruptions in the flow of life energy (Qi) circulating in channels called meridians in the body. Acupuncture aims to correct the disrupted energy flow by inserting needles into specific points on the meridians in the body. The key to achieving the desired result in acupuncture is knowing where to stimulate the skin and inserting the needles appropriately. As one of the oldest medical treatments and an important part of traditional Chinese medicine, acupuncture has been widely used in the treatment of various diseases for at least 3000 years. Meanwhile, it is also one of the most popular complementary and alternative approaches, supported by the World Health Organization (WHO) and the National Institutes of Health (NIH). Numerous studies have reported that acupuncture is widely used in the treatment of obesity. Current evidence-based reviews have shown that acupuncture is effective in treating obesity. It has been suggested that acupuncture is an effective treatment for simple obesity rather than a placebo effect. In our study, the investigators aimed to reveal the effect of acupuncture on sarcopenia and obesity in patients with sarcopenic obesity.
- Conditions
- Sarcopenic Obesity, Acupuncture Treatment, Exercise
- Being tested
- Diet and exercise, Acupuncture
- Keywords
- Sarcopenic Obesity, acupuncture, exercise, sarcopenia, obesity
- Medical subject headings
- Motor Activity, Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and exerciseOther
This group will receive a total of 10 sessions per week, 2 days a week consisting of aerobic exercises, resistance exercises, posture and balance exercises, and breathing exercises, as well as a diet program targeting sarcopenic obesity.
AcupunctureOther
The second group will receive acupuncture treatment in addition to diet and exercise. Acupuncture treatment will be applied twice a week for a total of 10 sessions, with each session lasting at least 20 minutes. The acupuncture points the investigators will use in the treatment have been determined based on previous research and are as follows: body acupuncture points ST25, ST36, SP15, LI4, Ren12, Ren6, Ki3, GB34, SP3, SP6, Liv8, SJ-6, Du 20, Yin Tang, Tai Yin; ear acupuncture points are shenmen, large intestine, hunger, and mouth points.
| Study group | Role | What they receive |
|---|---|---|
| exercise+diet | Active comparator | This group will receive a total of 10 sessions per week, 2 days a week consisting of aerobic exercises, resistance exercises, posture and balance exercises, and breathing exercises, as well as a diet program targeting sarcopenic obesity. Receives: Other: Diet and exercise |
| acupuncture+exercise+diet | Active comparator | The second group will receive acupuncture treatment in addition to diet and exercise. Acupuncture treatment will be administered twice a week for a total of 10 sessions, with each session lasting at least 20 minutes. The acupuncture points used in the treatment have been determined based on previous research and are as follows: body acupuncture points ST25, ST36, SP15, LI4, Ren12, Ren6, Ki3, GB34, SP3, SP6, Liv8, SJ-6, Du 20, Yin Tang, Tai Yin; ear acupuncture points are shenmen, large intestine, hunger, and mouth points. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular skeletal muscle mass
Body composition was assessed using a DEXA scanner (Lunar iDXA; GE Healthcare, 3030 Ohmeda Drive, Madison, WI 53718, USA). Participants' weight, muscle mass and lean mass values were recorded. ASM was calculated as the sum of the bone-free lean mass of the four limbs.
Measured: baseline-Week 6-Week 12
weight
The weight was measured with a standardized weight scale.
Measured: baseline-week 6-week 12
body mass index
BMI was calculated as weight in kilograms divided by height in meters squared (kg/m²).
Measured: baseline-week 6-week 12
Secondary outcomes (6)
hand grip strength
Muscle strength was evaluated by measuring handgrip strength with a validated and reliable Baseline hydraulic hand dynamometer (Inc., White Plains, NY 10602, USA)8. Grip strength was assessed with the participant seated in a chair, the shoulder in a neutral position, and the elbow flexed at 90°; three maximal grip efforts were performed with each hand, both right and left. The highest value obtained was taken as the grip strength. A rest interval of at least 30 seconds was allowed between measurements.
Measured: baseline-week 6-week 12
waist circumference and hip circumference measurement
Waist and hip circumference were measured with a tape measure.
Measured: baseline-week 6-week 12
Sit-Up and Stand-Up Test (from a Chair)
Participants were seated in a standard-height, armless chair with their feet flat on the floor, approximately shoulder-width apart. They were instructed to cross their arms over their chest and, upon the command "start," to stand up and sit down fully five times as quickly as possible without using their arms for support. The timer started with the "start" command and stopped at the end of the fifth repetition when the participant reached a fully upright position. The total time taken to complete all five repetitions was recorded in seconds. A shorter completion time was considered to indicate better lower extremity functional performance.
Measured: baseline-week 6-week 12
Walking speed of 4 meters
For the gait speed test, participants were asked to walk 4 meters at their usual pace and the elapsed time was measured with a stopwatch. Gait speed was calculated in meters per second (m/s).
Measured: baseline-week 6-week 12
Sarcopenia Quality of Life Scale (SarQoL)
Sarcopenia-related quality of life was assessed using the validated Turkish version of the Sarcopenia Quality of Life questionnaire (SarQoL®). The SarQoL® is a self-administered, sarcopenia-specific questionnaire consisting of 22 questions and 55 items covering seven domains of health-related quality of life. The total score ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: baseline-week 6-week 12
Obesity-Weight Loss Quality of Life Scale (OWLQOL)
Obesity- and weight-loss-related quality of life was assessed using the validated Turkish version of the Obesity and Weight-Loss Quality of Life Questionnaire (OWLQOL). The OWLQOL is a disease-specific, self-administered questionnaire consisting of 17 items rated on a seven-point Likert scale. The total score is standardized to a range of 0-100, with higher scores indicating better obesity- and weight-loss-related quality of life.
Measured: baseline-week 6-week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start30 Apr 2024
- Primary completion20 Aug 2026
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was planned as a single-center, prospective, randomized controlled trial. Patients diagnosed with sarcopenic obesity according to WHO, FNIH, and EWGSOP2 guidelines will be included in the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşe Ukbe Baykut
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Bilkent Sehir Hastanesi
- Responsible party
- Sponsor-investigator, Ayşe Ukbe Baykut, Ankara City Hospital Bilkent
- Investigators
- Ayşe U Baykut, M.D, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797140
- Sponsor's protocol ID
- ACHBİLKENTAUBAYKUT005
- Acronym
- Sarcopenia
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I haven't decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture on Sarcopenia and Obesity in Patients With Sarcopenic Obesity.
- ClinicalTrials.gov ID
- NCT07797140
- Acronym / sponsor ID
- Sarcopenia / ACHBİLKENTAUBAYKUT005
- Conditions
- Sarcopenic Obesity, Acupuncture Treatment, Exercise
- Keywords
- Sarcopenic Obesity, acupuncture, exercise, sarcopenia, obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ayşe Ukbe BaykutUniversity, hospital or other
- Collaborators
- Ankara Bilkent Sehir Hastanesi
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 1 Sep 2026 (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.
Sarcopenia is defined by the European Working Group on Sarcopenia in Older People (EWGSOP) as "a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, carrying a risk of adverse outcomes such as physical disability, fractures, falls, impaired quality of life, and death. Obesity is classified according to the Body Mass Index (BMI), which is calculated by dividing weight in kilograms by the square of height in meters. According to the World Health Organization and most current guidelines for Western societies, obesity is defined as a BMI ≥ 30 kg/m². Sarcopenic obesity was first defined by Baumgartner as the co-occurrence of sarcopenia and obesity, measured using DEXA (10). Sarcopenic obesity is defined as the co-occurrence of high adiposity and sarcopenia; a term originally coined to describe low skeletal muscle mass, strength, and physical function, initially diagnosed in the elderly but present across the entire age spectrum. Combining the effects of both sarcopenia and obesity, sarcopenic obesity has been found to be associated with lower quality of life and greater disability, morbidity, and mortality compared to obesity or sarcopenia alone. Acupuncture is derived from the Latin words for needle (acus) and piercing (punctura). In Western languages, it is written as acupuncture. In traditional Chinese medicine, it is believed that diseases are caused by disturbances in the flow of life energy (Qi) circulating in channels called meridians in the body. Acupuncture aims to correct this disrupted energy flow by inserting needles into specific points along the meridians in the body. Numerous studies have reported that acupuncture is widely used in the treatment of obesity. Current evidence-based reviews have shown that acupuncture is effective in treating obesity. It has been suggested that acupuncture is an effective treatment for simple obesity rather than a placebo effect.
The literature contains many studies on acupuncture in the treatment of obesity. However, there are no studies on acupuncture in sarcopenic obesity. Our study aimed to determine the effect of acupuncture on sarcopenia and obesity in patients with sarcopenic obesity.
Detailed description
Sarcopenic obesity was first defined by Baumgartner as the co-occurrence of sarcopenia and obesity, measured using DEXA (dual-energy x-ray absorptiometry). It is characterized by the simultaneous occurrence of high adiposity and sarcopenia; the term was initially coined to describe low skeletal muscle mass, strength, and physical function, initially diagnosed in the elderly but present across the entire age spectrum. Combining the effects of both sarcopenia and obesity, sarcopenic obesity has been associated with a lower quality of life and greater disability, morbidity, and mortality compared to obesity or sarcopenia alone. The lack of accurate prevalence rates for sarcopenic obesity stems from the absence of a consistent definition for sarcopenia or obesity. In a population-based cohort using National Health and Nutrition Examination Survey (NHANES) data applying FNIH criteria, sarcopenic obesity rates were found to be 12.6% in men and 33.5% in women, and these rates increased with age, reaching 27.5% in men and 48% in women over 80 years of age. The pathogenesis of sarcopenic obesity is multifactorial; the interaction between aging, sedentary lifestyle, unhealthy dietary habits, and insulin resistance, systemic inflammation, and oxidative stress leads to a quantitative and qualitative decrease in muscle mass and function, and a parallel increase in fat mass. Common etiological factors affect both muscle and fat mass. Current definitions of sarcopenic obesity are based on individual definitions of sarcopenia and obesity, but there is currently no consensus defining cut-off values for either of these conditions, making it difficult to reach an accurate diagnosis of sarcopenic obesity. In sarcopenic obesity, anthropometric measurements (weight, BMI, waist circumference) are normal or high, and imaging (DEXA, BIA, CT, MRI) shows high fat mass and low muscle mass. Acupuncture is derived from the Latin words for needle (acus) and piercing (punctura). In Western languages, it is written as acupuncture. In traditional Chinese medicine, it is believed that diseases are caused by disruptions in the flow of life energy (Qi) circulating in channels called meridians in the body. Acupuncture aims to correct the disrupted energy flow by inserting needles into specific points on the meridians in the body. The key to achieving the desired result in acupuncture is knowing where to stimulate the skin and inserting the needles appropriately. As one of the oldest medical treatments and an important part of traditional Chinese medicine, acupuncture has been widely used in the treatment of various diseases for at least 3000 years. Meanwhile, it is also one of the most popular complementary and alternative approaches, supported by the World Health Organization (WHO) and the National Institutes of Health (NIH). Numerous studies have reported that acupuncture is widely used in the treatment of obesity. Current evidence-based reviews have shown that acupuncture is effective in treating obesity. It has been suggested that acupuncture is an effective treatment for simple obesity rather than a placebo effect. In our study, the investigators aimed to reveal the effect of acupuncture on sarcopenia and obesity in patients with sarcopenic obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was planned as a single-center, prospective, randomized controlled trial. Patients diagnosed with sarcopenic obesity according to WHO, FNIH, and EWGSOP2 guidelines will be included in the study.
| Arm | Type | Receives |
|---|---|---|
| exercise+diet | Active comparator | Other: Diet and exerciseThis group will receive a total of 10 sessions per week, 2 days a week consisting of aerobic exercises, resistance exercises, posture and balance exercises, and breathing exercises, as well as a diet program targeting sarcopenic obesity. |
| acupuncture+exercise+diet | Active comparator | Other: AcupunctureThe second group will receive acupuncture treatment in addition to diet and exercise. Acupuncture treatment will be administered twice a week for a total of 10 sessions, with each session lasting at least 20 minutes. The acupuncture points used in the treatment have been determined based on previous research and are as follows: body acupuncture points ST25, ST36, SP15, LI4, Ren12, Ren6, Ki3, GB34, SP3, SP6, Liv8, SJ-6, Du 20, Yin Tang, Tai Yin; ear acupuncture points are shenmen, large intestine, hunger, and mouth points. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having the mental and physical capacity to adapt to the work process
- Being between 18-75 years of age
- Being able to ambulate independently or with support
- Having a body mass index (BMI) ≥ 30 kg/m2
Key exclusion criteria (9 listed)
- Pregnancy
- Infection
- Pacemaker
- Peripheral circulatory disorder
- Known concomitant malignancy, end-stage organ failure
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 |
|---|---|---|
| Diet and exerciseThis group will receive a total of 10 sessions per week, 2 days a week consisting of aerobic exercises, resistance exercises, posture and balance exercises, and breathing exercises, as well as a diet program targeting sarcopenic obesity. | Other | exercise+diet |
| AcupunctureThe second group will receive acupuncture treatment in addition to diet and exercise. Acupuncture treatment will be applied twice a week for a total of 10 sessions, with each session lasting at least 20 minutes. The acupuncture points the investigators will use in the treatment have been determined based on previous research and are as follows: body acupuncture points ST25, ST36, SP15, LI4, Ren12, Ren6, Ki3, GB34, SP3, SP6, Liv8, SJ-6, Du 20, Yin Tang, Tai Yin; ear acupuncture points are shenmen, large intestine, hunger, and mouth points. | Other | acupuncture+exercise+diet |
Primary outcome
Appendicular skeletal muscle mass
Time frame: baseline-Week 6-Week 12
Body composition was assessed using a DEXA scanner (Lunar iDXA; GE Healthcare, 3030 Ohmeda Drive, Madison, WI 53718, USA). Participants' weight, muscle mass and lean mass values were recorded. ASM was calculated as the sum of the bone-free lean mass of the four limbs.
weight
Time frame: baseline-week 6-week 12
The weight was measured with a standardized weight scale.
body mass index
Time frame: baseline-week 6-week 12
BMI was calculated as weight in kilograms divided by height in meters squared (kg/m²).
6 secondary outcomes
hand grip strength
Time frame: baseline-week 6-week 12
waist circumference and hip circumference measurement
Time frame: baseline-week 6-week 12
Sit-Up and Stand-Up Test (from a Chair)
Time frame: baseline-week 6-week 12
Walking speed of 4 meters
Time frame: baseline-week 6-week 12
Sarcopenia Quality of Life Scale (SarQoL)
Time frame: baseline-week 6-week 12
Obesity-Weight Loss Quality of Life Scale (OWLQOL)
Time frame: baseline-week 6-week 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 25 Sep 2026.
- Individual participant dataSharing planned: No. I haven't decided yet.
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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.
Ayşe U Baykut, M.D principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and exercise and Acupuncture in people with Sarcopenic Obesity and Acupuncture Treatment, run by Ayşe Ukbe Baykut at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 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 Turkey (Türkiye). 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?
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?
Appendicular skeletal muscle mass (time frame: baseline-Week 6-Week 12). The study lists 3 primary outcomes in all. 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 25 Sep 2026.