Overweight and/or Obesity, Weight Management
Conditions
Keywords
ecnoglutide, glucagon-like peptide-1 (GLP-1), obesity, overweight, weight management
Brief summary
The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity
Detailed description
In this study, eligible participants will be randomized to receive either oral ecnoglutide tablet or placebo once daily for up to 3 weeks (Cohort C1) or 4 weeks (Cohort C2 or C6), or once weekly for up to 24 weeks (Cohort C3, C4 and C5), including a dose escalation period.
Interventions
DRUGecnoglutide tablets
oral tablets
DRUGplacebo with matching dosage
oral tablets
Sponsors
Hangzhou Sciwind Biosciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. At the time of informed consent, with BMI in the range of 24.0 to 35.0 kg/m2 (including the threshold), body weight \>60.0 kg for male, and weight \>50.0 kg for female; 2. Self-declaration of body weight change \<5% within 3 months prior to informed consent ;
Exclusion criteria
1. Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome; 2. Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows TI-RADS≥ class 3), thyroid cancer, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc. 3. Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to acute stroke, acute coronary syndrome, heart failure, arrhythmia, etc. 4. Diagnosis of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, diabetic gastroparesis, diabetic diarrhea, clinical gastric emptying abnormalities (such as pyloric obstruction), etc. 5. History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period; 6. HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening; 7. Clinical laboratory test results with clinical significance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events | up to day 204 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of oral ecnoglutide tablet | up to day 204 | Cmax, Tmax and AUC |
| Change of body weight from baseline | up to day 204 | — |
| Change of BMI from baseline | up to day 204 | — |
| Change of waist circumference from baseline | up to day 204 | — |
| Change of hip circumference from baseline | up to day 204 | — |
| Change of neck circumference from baseline | up to day 204 | — |
| Change of waist/hip ratio from baseline | up to day 204 | — |
| Change of fasting blood glucose from baseline | up to day 204 | — |
| Change of fasting insulin from baseline | up to day 204 | — |
| Change of lipid profile from baseline | up to day 204 | — |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJintong Li, Dr
China-Japan Friendship Hospital
Outcome results
None listed