Valid MeSH Conditiongs
Conditions
Brief summary
Use these resources to provide understandable information about this study to patients, families, and health care providers:
Interventions
DRUGJMT206 injection
JMT206 injection administered subcutaneously (SC) once a week
COMBINATION_PRODUCTSemaglutide injection
Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased.
DRUGPlacebo injection
Placebo administered subcutaneously (SC) once a week.
Sponsors
Shanghai JMT-Bio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\~65 (including threshold values), male or female participants; 2. BMI ≥ 30 kg/m²; 3. Weight change \<5% within the 3 months prior to screening 4. Voluntarily sign the informed consent form before the trial..
Exclusion criteria
1\) Those known to have a history of allergy to any component or related preparations in the investigational drug and its excipients, or have severe allergic diseases or allergic constitution; 2) Participants with a history of diabetes mellitus or hypoglycemic episodes; 3) Obesity is related to medication or diseases; Or weight gain caused by non-fat content; or monogene mutationsobesity; 4) History of weight loss surgery and/or treatment within the past year; 5) History of severe gastrointestinal disease or gastrointestinal surgery, clinically significant gastric emptying abnormalities, or long-term use of medications directly affecting gastrointestinal motility; 6) Having comorbidities known to affect skeletal muscle proteins; 7) A history of acute or chronic pancreatitis; 8) Acute gallbladder disease within one year prior to screening; 9) Previous or family history of medullary thyroid carcinoma or type 2 endocrine adenomatosis; 10) Severe cardiovascular or cerebrovascular events within 6 months prior to screening; 11) Any type of treated or untreated malignant tumor within 5 years prior to screening; 12) History of severe mental illness; 13) Use of drugs or products that may cause weight changes within 3 months prior to screening; 14) Use of drugs or products affecting skeletal muscle synthesis within 3 months prior to screening; 15) Participants deemed otherwise unsuitable for this trial by the investigator. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AE) assessed by CTCAE v6.0 | Baseline through week 19 |
Countries
China
Contacts
CONTACTClinical Trials Information Group officer
Outcome results
None listed