Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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 once weekly for up to 24 weeks (Cohort C3 and C4), including a dose escalation period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral ecnoglutide dose 1 | Experimental | once daily |
|
| oral ecnoglutide dose 2 | Experimental | once daily |
|
| oral ecnoglutide dose 3 | Experimental | once weekly |
|
| oral ecnoglutide dose 4 | Experimental | once weekly |
|
| placebo dose 1 | Placebo Comparator | once daily |
|
| placebo dose 2 | Placebo Comparator | once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ecnoglutide tablets | Drug | oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events | up to day 204 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of oral ecnoglutide tablet | Cmax, Tmax and AUC | up to day 204 |
| Change of body weight from baseline | up to day 204 | |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenecity of oral ecnoglutide tablet | up to day 204 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jintong Li, Dr | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo with matching dosage | Drug | oral tablets |
|
| 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided