ObesityNCT06316310
Effect of Acupoint Thread Embedding on Obesity
A study testing acupoint thread embedding in people with Obesity, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of acupoint thread embedding on losing weight in obese patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- acupoint thread embedding
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females aged 18~45 years old;
- BMI≥24.0 kg/m2；
- WC≥80cm ; recommended BMI and WC threshold value to define overweight in China;
- Stable weight change (increase or decrease of ≤4 kg) within 3 months prior to the start of the test;
- Agree to participate in the trial and sign a written informed consent form;
Who cannot join
- Secondary obesity caused by drugs, or neuro-endocrine-metabolic disorders (such as thalamic disease, hypopituitarism, etc.);
- History of bariatric surgery (gastric reduction, liposuction, etc.);
- Are taking medications that may affect the results of the trial (weight):
- Severe ulcers, abscesses, skin infections, etc. at the acupuncture site;
- Severe heart, brain, lung, liver and kidney insufficiency, hematopoietic system disease or other serious diseases;
- Participated in other clinical medical trial studies in the past 1 month;
Show all 9Show fewer
- History of acupoint thread embedding in the past 6 months;
- Alcoholism, drug abuse, or smoking (change in smoking habits within the past 2 months or a plan to quit smoking during the study period);
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071
About this study
Official title: The Effect and Safety of Acupoint Thread Embedding on Over-weight and Obesity Treatment : A Randomized, Single-Blind, Sham- Controlled Study
The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of acupoint thread embedding on losing weight in obese patients.
Read the detailed description
Obesity refers to a complex chronic disease in which there is excessive accumulation of body fat. As of 2016, there were more than 650 million obese people worldwide, and it is expected to reach 1.12 billion by 2030, with at least 2.8 million deaths due to obesity each year, according to surveys. In Europe, 60 percent of the population is already overweight or obese. The incidence of obesity is also increasing rapidly in China, with a recent report by The Lancet showing that the number of obese people in China has reached 85 million, making it the country with the highest number of obese people in the world. In 2002, the China Obesity Task Force recommended threshold value to define overweight as Body Mass Index (BMI) of ≥ 24 kg/m2, a waist circumference (WC) ≥of 85 cm for men and a WC ≥ 80 cm for women, or a Waist-to-Hip Ratio (WHR) of ≥ 0.9 for men and a WHR ≥ 0.8 for women, and to define obesity as a BMI ≥ 28 kg/m2. Studies have shown that Asian populations have higher health risks at the same BMI and WC levels due to the distribution of adipose tissue. Acupoint thread embedding is a widely recognized therapy to lose weight in clinical practice.But there are some doubts about the effectiveness of acupoint thread embedding versus sham acupoint thread embedding in treating obesity due to its lack of medical evidence.
This randomized placebo-controlled clinical trial is aimed to investigate the effect and safety of acupoint thread embedding (ATE) in obese patients. The investigators designed a protocol for a randomized controlled trial, in which 132 eligible patients will be randomly assigned to one of the two groups: the ATE group (receiving ATE treatment with health education) and the sham acupoint thread embedding (SATE) group (receiving SATE treatment with health education). A total of 6 sessions of interventions will be given for consecutive 12 weeks, followed by 12 weeks follow-up period. Each session of ATE or SATE treatment will last for about 30 minutes. The primary outcome is the change of the body mass index (BMI) at week 12. The secondary outcomes include the change of patient's body weight and body circumference, results from the blood tests (FBG, LDL-C, HDL-C, TG and TC), the abdominal visceral fat tissue thickness scanned by FibroScan, data collected from the body composition analyzer, and the scores of the impact of weight on quality of life (IWQOL-Lite), the well-being index (WHO-5), visual analog scale (VAS) of appetite and hamilton anxiety scale(HAMA). All adverse effects will be accessed by the treatment emergent symptom scale (TESS) from baseline to the follow-up period. The body weight and circumferences，BMI，IWQOL-Lite, WHO-5, VAS, and the HAMA, will be calculated at baseline, week 6, week 12, and week 24. blood tests，FibroScan and the body composition analyzer's data will be calculated at baseline，week 12 and week24. All patients will be provided with the same health education brochure to choose more beneficial personalized lifestyle during the 12-week intervention period.
All analyses will be performed on the intention-to-treat (ITT) population of participants who have at least one treatment. Missing data will be handled using the multiple imputation method, on the assumption that values at each time point follow a specific distribution calculated by the computer software R V.3.5. The primary outcome is the change of the body mass index (BMI) at week 12. Linear mixed effects models will be used for analyses with the use of the statistical software SPSS V.29.0. The t-test will be used to compare the measurement data between either two groups from the baseline to follow-up; the rank sum test will be used for ranked data while the Chi-squared test will be used to analyze categorical data. The significance level that will be used for statistical analysis with 2-tailed testing will be 2.5%. Data values will mainly be presented as Mean±SD. The findings from this trial will help further explore the efficacy and safety of ATE on losing weight for patients with obesity, as well as determine the differences between the ATE and SATE treatment.
- Conditions
- Obesity
- Being tested
- acupoint thread embedding
- Keywords
- Acupoint Thread Embedding, Sham Acupoint Thread Embedding, Obesity, Randomized Controlled Trial
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoint thread embeddingOther
Also called sham acupoint thread embedding
Acupoint embedding therapy:Main acupoints: Shangguan (CV-13), Xiaguan (CV-10), Tianshu (ST-25), Daheng (SP-15), Fenglong (ST-40), Qihai (CV-6), Zhongguan (CV-12), Zusanli (ST-36), Quchi (LI-11), Guanyuan (CV-4), Wailing (ST-26), Daju (ST-27), Shuidao (ST-28), Daimai (GB-26), Liangmen (ST-21), Ashi acupoints , where local fat accumulation in the abdomen. Methods of operation: With the patient in the prone position and all acupoints routinely sterilized, the acupuncturist will use sterile forceps to insert a 3-0 × 2-cm poly-p-dimethyl-hydroxy-oxazolone (PDO) thread into the tip of the #6 (0.6 mm × 60 mm) disposable embedded thread needle. The tissue around the area of the acupuncture point will be lifted with the thumb and forefinger of the non-dominant hand and the needle will be inserted into the acupuncture point to a depth of 1.5 cm with the dominant hand. Each treatment will last maximum of 10 minutes and the intervention will be repeated every 2 weeks for a total of 6 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Acupoint Thread Embedding group+health education | Active comparator | Acupuncture thread embedding (ATE), extension and development of acupuncture therapy, which emerged in mid 1950s, is an acupoint stimulation technique which sterile biodegradable threads (such as polydioxanone (PDO) threads) are inserted into acupuncture points, by using hollow core embedding needles. The aim of this therapy is provide long term stimulation of acupoints, making this technique one of the most commonly used methods for treating obesity. Receives: Other: acupoint thread embedding |
| Sham Acupoint Thread Embedding group+health education | Sham comparator | Sham acupoint thread embedding method in this study is set as the Sham acupoint thread embedding manipulated at the same main acupoints won't be put into trocar and de qi sensation will not be obtained.
The aim of the sham acupoint thread embedding is to eliminate the possible placebo effect of ATE treatment. Receives: Other: acupoint thread embedding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
one of the criteria for evaluating the body weight and health status of a person. BMI = weight (kg)/height (m)2. Each subject will be provided with a free Bluetooth Internet-enabled scale to monitor their weight at regular intervals, and the researcher will be able to access the data from the backend.
Measured: week12
Secondary outcomes (12)
Change in body weight
The change in body weight at the end of the intervention compared to the baseline.
Measured: week0, week6, week12, week24
Body Mass Index (BMI)
one of the criteria for evaluating the body weight and health status of a person. BMI = weight (kg)/height (m)2. Each subject will be provided with a free Bluetooth Internet-enabled scale to monitor their weight at regular intervals, and the researcher will be able to access the data from the backend
Measured: week0, week6, week24
Changes in body circumference
Waist circumference (WC), hip circumference (HC), waist-hip ratio (WHR), waist-height ratio (WHtR), and the average value of the changes in each circumference at the end of the intervention were calculated compared with the baseline. WHR=WC/HC; WHtR=WC/height .
Measured: week0, week6, week12, week24
Body composition analysis
Evaluating changes in body fat percentage or composition by using bioelectrical impedance analysis (BIA) device (InBody770; Biospace, Seoul, Korea)., which allows for high-density body composition measurements, including muscle mass, body water content, body fat percentage, visceral fat grade, and other body components, by bioelectrical impedance analysis.
Measured: week0, week12, week24
Changes in liver fat content
Liver fat changes are quantitatively calculated with FibroScan.
Measured: week0, week12, week24
Fasting blood glucose (FPG)
glucose concentration in the blood in the early morning fasting, which can reflect the function of pancreatic β-cells,HOMA-IR, Insulin level.
Measured: week0, week12, week24
Blood lipid profile
including Low-density Lipoprotein (LDL), High density lipoprotein (HDL), triglyceride (TG), cholesterol (TC), reflects the lipid metabolism within the body.
Measured: week0, week12, week24
Impact of Weight on Quality-of-Life Scale (IWQOL-Lite)
a 31-item self-report scale consisting of a total score and individual scores on 5 dimensions, i.e., physical functioning, self-esteem, sexuality, public stress, and work, to assess the quality of life of obese patients
Measured: week0, week6, week12, week24
Well-Being Index (WHO-5)
shot, self-administered subjective measure of well-being over the last two weeks. It consists of 5 positively worded item that is rated on 0-6 which is 0 means at no time and 5 is all the time.
Measured: week0, week6, week12, week24
Visual analog scale (VAS) of appetite
This method relies on a line segment of 100 mm or 150mm in length, with the two ends pointing to "I have no appetite at all" and "I have a very good appetite" respectively. Subjects mark the line according to their level of appetite. The patient was determined to have a reduced appetite if the measured line segment was <50 mm or 70 mm.
Measured: week0, week6, week12, week24
Hamilton Anxiety Scale (HAMA)
The CCMD-3 Chinese Diagnostic Criteria for Mental Disorders lists it as an important diagnostic tool for anxiety disorders, and is often used clinically as the basis for the diagnosis and degree classification of anxiety disorders. The total score can better reflect the severity of anxiety symptoms, and can be used to evaluate the severity of anxiety symptoms in patients with anxiety and depressive disorders and evaluate the effects of various drugs and psychological interventions. According to the information provided by the Chinese scale collaboration group: the total score is ≥ 29 points, which may be severe anxiety; ≥ 21 points, there must be significant anxiety; ≥ 14 points, there is definitely anxiety; More than 7 points, there may be anxiety; If the score is less than 7, there are no anxiety symptoms.
Measured: week0, week6, week12, week24
Adverse effects
Any adverse event (described as unfavourable or unintended signs, symptoms or diseases occurring during the trial) related to the intervention will be reported by patients and practitioners and accessed by the Treatment Emergent Symptom Scale (TESS) which is used as an associated indicator to mainly evaluate the safety of acupoint thread embedding treatment in this trial.
Measured: week6, week12, week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start15 Mar 2024
- Primary completion24 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- All eligible participants will be randomly assigned into two group at a ratio of 1:1, the Acupoint Thread Embedding group and the Sham Acupoint Thread Embedding group (the control group). group).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316310
- Sponsor's protocol ID
- XSF20240312
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data in this trial will be publicly available from the corresponding author upon reasonable request. All data and the protocol will be available after publication in peer-reviewed international journals for 3 years.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Acupoint Thread Embedding on Over-weight and Obesity Treatment : A Randomized, Single-Blind, Sham- Controlled Study
- ClinicalTrials.gov ID
- NCT06316310
- Acronym / sponsor ID
- XSF20240312
- Conditions
- Obesity
- Keywords
- Acupoint Thread Embedding, Sham Acupoint Thread Embedding, Obesity, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 18 Mar 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 investigators describe a protocol for a randomized controlled trial to find out the effect and safety of acupoint thread embedding on losing weight in obese patients.
Detailed description
Obesity refers to a complex chronic disease in which there is excessive accumulation of body fat. As of 2016, there were more than 650 million obese people worldwide, and it is expected to reach 1.12 billion by 2030, with at least 2.8 million deaths due to obesity each year, according to surveys. In Europe, 60 percent of the population is already overweight or obese. The incidence of obesity is also increasing rapidly in China, with a recent report by The Lancet showing that the number of obese people in China has reached 85 million, making it the country with the highest number of obese people in the world. In 2002, the China Obesity Task Force recommended threshold value to define overweight as Body Mass Index (BMI) of ≥ 24 kg/m2, a waist circumference (WC) ≥of 85 cm for men and a WC ≥ 80 cm for women, or a Waist-to-Hip Ratio (WHR) of ≥ 0.9 for men and a WHR ≥ 0.8 for women, and to define obesity as a BMI ≥ 28 kg/m2. Studies have shown that Asian populations have higher health risks at the same BMI and WC levels due to the distribution of adipose tissue. Acupoint thread embedding is a widely recognized therapy to lose weight in clinical practice.But there are some doubts about the effectiveness of acupoint thread embedding versus sham acupoint thread embedding in treating obesity due to its lack of medical evidence.
This randomized placebo-controlled clinical trial is aimed to investigate the effect and safety of acupoint thread embedding (ATE) in obese patients. The investigators designed a protocol for a randomized controlled trial, in which 132 eligible patients will be randomly assigned to one of the two groups: the ATE group (receiving ATE treatment with health education) and the sham acupoint thread embedding (SATE) group (receiving SATE treatment with health education). A total of 6 sessions of interventions will be given for consecutive 12 weeks, followed by 12 weeks follow-up period. Each session of ATE or SATE treatment will last for about 30 minutes. The primary outcome is the change of the body mass index (BMI) at week 12. The secondary outcomes include the change of patient's body weight and body circumference, results from the blood tests (FBG, LDL-C, HDL-C, TG and TC), the abdominal visceral fat tissue thickness scanned by FibroScan, data collected from the body composition analyzer, and the scores of the impact of weight on quality of life (IWQOL-Lite), the well-being index (WHO-5), visual analog scale (VAS) of appetite and hamilton anxiety scale(HAMA). All adverse effects will be accessed by the treatment emergent symptom scale (TESS) from baseline to the follow-up period. The body weight and circumferences，BMI，IWQOL-Lite, WHO-5, VAS, and the HAMA, will be calculated at baseline, week 6, week 12, and week 24. blood tests，FibroScan and the body composition analyzer's data will be calculated at baseline，week 12 and week24. All patients will be provided with the same health education brochure to choose more beneficial personalized lifestyle during the 12-week intervention period.
All analyses will be performed on the intention-to-treat (ITT) population of participants who have at least one treatment. Missing data will be handled using the multiple imputation method, on the assumption that values at each time point follow a specific distribution calculated by the computer software R V.3.5. The primary outcome is the change of the body mass index (BMI) at week 12. Linear mixed effects models will be used for analyses with the use of the statistical software SPSS V.29.0. The t-test will be used to compare the measurement data between either two groups from the baseline to follow-up; the rank sum test will be used for ranked data while the Chi-squared test will be used to analyze categorical data. The significance level that will be used for statistical analysis with 2-tailed testing will be 2.5%. Data values will mainly be presented as Mean±SD. The findings from this trial will help further explore the efficacy and safety of ATE on losing weight for patients with obesity, as well as determine the differences between the ATE and SATE treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All eligible participants will be randomly assigned into two group at a ratio of 1:1, the Acupoint Thread Embedding group and the Sham Acupoint Thread Embedding group (the control group). group).
| Arm | Type | Receives |
|---|---|---|
| Acupoint Thread Embedding group+health education | Active comparator | Other: acupoint thread embeddingAcupuncture thread embedding (ATE), extension and development of acupuncture therapy, which emerged in mid 1950s, is an acupoint stimulation technique which sterile biodegradable threads (such as polydioxanone (PDO) threads) are inserted into acupuncture points, by using hollow core embedding needles. The aim of this therapy is provide long term stimulation of acupoints, making this technique one of the most commonly used methods for treating obesity. |
| Sham Acupoint Thread Embedding group+health education | Sham comparator | Other: acupoint thread embeddingSham acupoint thread embedding method in this study is set as the Sham acupoint thread embedding manipulated at the same main acupoints won't be put into trocar and de qi sensation will not be obtained. The aim of the sham acupoint thread embedding is to eliminate the possible placebo effect of ATE treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females aged 18~45 years old;
- BMI≥24.0 kg/m2；
- WC≥80cm ; recommended BMI and WC threshold value to define overweight in China;
- Stable weight change (increase or decrease of ≤4 kg) within 3 months prior to the start of the test;
- Agree to participate in the trial and sign a written informed consent form;
Key exclusion criteria (9 listed)
- Secondary obesity caused by drugs, or neuro-endocrine-metabolic disorders (such as thalamic disease, hypopituitarism, etc.);
- History of bariatric surgery (gastric reduction, liposuction, etc.);
- Are taking medications that may affect the results of the trial (weight):
- Severe ulcers, abscesses, skin infections, etc. at the acupuncture site;
- Severe heart, brain, lung, liver and kidney insufficiency, hematopoietic system disease or other serious diseases;
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 |
|---|---|---|
| acupoint thread embeddingAlso: sham acupoint thread embeddingAcupoint embedding therapy:Main acupoints: Shangguan (CV-13), Xiaguan (CV-10), Tianshu (ST-25), Daheng (SP-15), Fenglong (ST-40), Qihai (CV-6), Zhongguan (CV-12), Zusanli (ST-36), Quchi (LI-11), Guanyuan (CV-4), Wailing (ST-26), Daju (ST-27), Shuidao (ST-28), Daimai (GB-26), Liangmen (ST-21), Ashi acupoints , where local fat accumulation in the abdomen. Methods of operation: With the patient in the prone position and all acupoints routinely sterilized, the acupuncturist will use sterile forceps to insert a 3-0 × 2-cm poly-p-dimethyl-hydroxy-oxazolone (PDO) thread into the tip of the #6 (0.6 mm × 60 mm) disposable embedded thread needle. The tissue around the area of the acupuncture point will be lifted with the thumb and forefinger of the non-dominant hand and the needle will be inserted into the acupuncture point to a depth of 1.5 cm with the dominant hand. Each treatment will last maximum of 10 minutes and the intervention will be repeated every 2 weeks for a total of 6 sessions. | Other | Acupoint Thread Embedding group+health education, Sham Acupoint Thread Embedding group+health education |
Primary outcome
Body Mass Index (BMI)
Time frame: week12
one of the criteria for evaluating the body weight and health status of a person. BMI = weight (kg)/height (m)2. Each subject will be provided with a free Bluetooth Internet-enabled scale to monitor their weight at regular intervals, and the researcher will be able to access the data from the backend.
12 secondary outcomes
Change in body weight
Time frame: week0, week6, week12, week24
Body Mass Index (BMI)
Time frame: week0, week6, week24
Changes in body circumference
Time frame: week0, week6, week12, week24
Body composition analysis
Time frame: week0, week12, week24
Changes in liver fat content
Time frame: week0, week12, week24
Fasting blood glucose (FPG)
Time frame: week0, week12, week24
Blood lipid profile
Time frame: week0, week12, week24
Impact of Weight on Quality-of-Life Scale (IWQOL-Lite)
Time frame: week0, week6, week12, week24
Well-Being Index (WHO-5)
Time frame: week0, week6, week12, week24
Visual analog scale (VAS) of appetite
Time frame: week0, week6, week12, week24
Hamilton Anxiety Scale (HAMA)
Time frame: week0, week6, week12, week24
Adverse effects
Time frame: week6, week12, week24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes. The data in this trial will be publicly available from the corresponding author upon reasonable request. All data and the protocol will be available after publication in peer-reviewed international journals for 3 years.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupoint thread embedding in people with Obesity, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
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 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: finished, as of the sponsor's last update on 24 Aug 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Mass Index (BMI) (time frame: week12). 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 24 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.