Thread Embedding Acupuncture Therapy for Weight Loss

Inclusion Criteria:

1. Body-mass index: a. BMI ≥ 28 kg/m2 or b. BMI ≥ 24 kg/m2 with the presence of atleast one of the following weight-related complications (treated or untreated):diabetes, hypertension, lipid metabolism disorders, obstructive sleep apnea,cardiovascular disease, knee osteoarthritis, hyperuricemia, fatty liver;

2. Male or female, age between 18 and 75 years at the time of signing informed consent;

3. No history of receiving thread embedding treatment;

4. History of at least one self-reported unsuccessful dietary effort and exerciseprogram to lose body weight;

5. Informed consent obtained.

Exclusion Criteria:

1. A self-reported change in body weight ≥ 5 kg within 90 days before screening;

2. Treatment with any medication for the indication of obesity within the past 90 daysbefore Screening;

3. Previous or planned (during the trial period) obesity treatment with surgery or abodyweight loss device. However, the following were allowed: (1) liposuction and/orabdominoplasty, if performed more than 1 year before screening; (2) lap banding, ifthe band had been removed more than 1 year before screening; (3) intragastricballoon, if the balloon had been removed more than 1 year before screening; or (4)duodenal-jejunal bypass sleeve, if the sleeve had been removed more than 1 yearbefore screening;

4. Have obesity induced by other endocrinologic disorders (for example, CushingSyndrome) or diagnosed monogenetic or syndromic forms of obesity (for example,Melanocortin 4 Receptor deficiency or Prader Willi Syndrome);

5. Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH)>6.0 mIU/Lor <0.35 mIU/L as measured by the central laboratory at screening;

6. Diagnosed with type 2 diabetes mellitus ≤180 days prior to the day of screening orthose who have taken treatment with oral agents that were unstable (differentdrug(s), dose, or dosing frequency) within the 90 days prior to screening;

7. Receipt of any acupuncture treatment for obesity within 90 days before screening;

8. Participation in any structured, monitored weight-loss program within 90 days beforescreening;

9. Active inflammatory bowel disease, celiac disease, chronic pancreatitis, or otherdisorder potentially causing malabsorption;

10. Any of the following severe cardiovascular diseases: myocardial infarction, stroke,heart failure, symptomatic peripheral vascular diseases, or hospitalization forunstable angina or transient ischemic attack within the last 6 months prior toscreening;

11. History of malignant neoplasms within the past 5 years prior to screening. Basal andsquamous cell skin cancer and any carcinoma in-situ are allowed;

12. Chronic respiratory, neurological, musculoskeletal or other disorders where, in thejudgement of the investigator, participants would have unacceptable risk ordifficulty in complying with the protocol;

13. Surgery scheduled for the duration of the trial, except for minor surgicalprocedures, in the opinion of the investigator;

14. Known or suspected abuse of alcohol or recreational drugs;

15. Female who was pregnant, breast-feeding, or intended to become pregnant, or was ofchild-bearing potential and not using a highly effective contraceptive method;

16. Known or suspected hypersensitivity to trial product or related products;

17. Participation in another clinical trial within 90 days before screening;

18. Any disorder, unwillingness, or inability, not covered by any of the other exclusioncriteria, which in the investigator's opinion might have jeopardised theparticipant's safety or compliance with the protocol.