Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| YN012-II-W204-AU | Other Identifier | Innogen Holdings PTY LTD |
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
This is a multicenter, double-blind, randomized, placebo-controlled phase Ⅱ study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YN-011 in subjects with overweight (27 kg/m2 ≤ BMI < 30 kg/m2, with at least one comorbidity) or obesity (BMI ≥ 30 kg/m2, with or without comorbidities). The entire study period will consist of a 2-week screening period, a 22-week double-blind treatment period, and a 4-week off-treatment follow-up period
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efsubaglutide 20 mg Quaque Week (QW) | Experimental | The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 mg, reaching the target dose of 20 mg, the total treatment last for 22weeks. |
|
| Efsubaglutide 40 mg QW | Experimental | The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg, reaching the target dose of 40 mg, the total treatment last for 22weeks. |
|
| Efsubaglutide Alfa 40 mg Q2W | Experimental | The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg,when reaching to target dose of 40 mg, administered the drug every 2weeks. the total treatment last for 22weeks. |
|
| Efsubaglutide Alfa 80 mg QW | Experimental | The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg→ 80mg, reaching the target dose of 80 mg, the total treatment last for 22weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efsubaglutide Alfa 20 mg QW | Drug | Efsubaglutide Alfa 20 mg QW |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change (%) of body weight from baseline after subcutaneous administration of YN-011 for 22 weeks | 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with body weight loss ≥ 5%, ≥ 10%, and ≥ 15% from baseline after subcutaneous | 22 weeks | |
| Absolute change from baseline in body weight (Kg) after subcutaneous administration for 22 weeks | 22 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| QINGHUA WANG | Contact | 862168788225 | dr.qwang@innogenpharm.com | |
| Karen Kaluhin | Contact | 02 8357 5242 | kkaluhin@canopycrcom.au |
| Name | Affiliation | Role |
|---|---|---|
| Karen Kaluhin | Canopy Clinical Sutherland Shire | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canopy Clinical Northern Beaches | Recruiting | Brookvale | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Efsubaglutide Alfa 80 mg Q4W | Experimental | The drug is administered once weekly, starting with a titration dose of 1 mg. The dose is up-titrated every 2 weeks in the sequence of 1 mg → 5 mg → 10 mg → 20 → 40mg→ 80mg,when reaching to target dose of 80 mg, administered the drug every 4weeks. the total treatment last for 22weeks. |
|
| Efsubaglutide Alfa 40 mg QW |
| Drug |
Efsubaglutide Alfa 40 mg QW |
|
| Efsubaglutide Alfa 40 mg Q2W | Drug | Efsubaglutide Alfa 40 mg Q2W |
|
| Efsubaglutide Alfa 80 mg QW | Drug | Efsubaglutide Alfa 80 mg QW |
|
| Efsubaglutide Alfa 80 mg Q4W | Drug | Efsubaglutide Alfa 80 mg Q4W |
|
| Placebo | Other | Placebo |
|
| Changes from baseline in BMI after subcutaneous administration for 22 weeks | 22 weeks |
| Changes from baseline in waist to hip circumference ratio after subcutaneous administration for 22 weeks | waist circumference, hip circumference, | 22 weeks |
| Changes from baseline in waist to height ratio after subcutaneous administration of YN-011 for 22 weeks | 22 weeks |
| Changes from baseline in systolic and diastolic blood pressure after subcutaneous administration for 22 weeks | 22 weeks |
| Changes from baseline in blood lipids (including TC, TG, LDL-C, and high-density lipoprotein cholesterol [HDL-C]) after subcutaneous administration for 22 weeks, percentage change from baseline, and ratio to baseline | 22 weeks |
| Changes from baseline in glycated hemoglobin (HbA1c) after administration subcutaneous for 22 weeks | 22 weeks |
| Changes from baseline in fasting plasma glucose(FPG) after subcutaneous administration of YN-011 for 22 weeks; | 22 weeks |
| Changes from baseline in fasting insulin after subcutaneous administration of YN-011 for 22 weeks; | insulin resistance by HOMA-IR, β-cell function by HOMA-β, | 22 weeks |
| Changes from baseline in blood uric acid after subcutaneous administration for 22 weeks, percentage change from baseline, and ratio to baseline | 22 weeks |
| Safety assessment will be conducted throught the study by Incidence of adverse events (AEs) and serious adverse events (SAEs); | 22 weeks |
| Safety assessment will be conducted throught the study by Mental health status via Patient Health Questionnaire-9 (PHQ-9) | 26 weeks |
| Safety assessment will be conducted throught the study by Mental health status via Columbia Suicide Severity Rating Scale (C-SSRS) | 26 weeks |
| Maximum plasma concentration (Cmax) of YN-011 via subcutaneous administration through the study | 22 weeks |
| Timepoint of maximum plasma concentration (Tmax) of YN-011 via subcutaneous administration | 22 weeks |
| Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t) of YN-011 via subcutaneous administration | 22 weeks |
| Elimination half-life (t1/2) of YN-011 via subcutaneous administration | 22 weeks |
| Apparent clearance (CL/F) of YN-011 via subcutaneous administration | 22 weeks |
| Apparent volume of distribution (Vz/F) of YN-011 via subcutaneous administration | 22 weeks |
| Trough concentration (Ctrough) of YN-011 via subcutaneous administration | 22 weeks |
| Incidence of anti-drug antibody (ADA) against YN-011 in serum before and after subcutaneous administration | 22 weeks |
| Incidence of neutralizing antibody (NAb) against YN-011 in serum before and after subcutaneous administration | NAb will be tested when ADA result is positive | 22 weeks |
| Changes from baseline in Dual Energy X-ray Absorptiometry [DEXA] data report (DEXA data inculding total fat mass, muscle mass, regional visceral fat mass and total lean body mass) after subcutaneous administration of YN-011 | 22 weeks |
| Canopy Clinical Sutherland Shire | Recruiting | Miranda | Australia |
|
| Canopy Clinical Altona North | Recruiting | North Altona | Australia |
|
| Fusion Clinical Research | Recruiting | Norwood | Australia |
|
| Canopy Clinical Wollongong | Recruiting | Wollongong | Australia |
|
| 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