The main purpose of the study is to evaluate the efficacy and safety of ecnoglutide injections versus placebo in obese participants with KOA.
In this Phase III study, eligible participants will be randomized into one of the two cohorts in a 1:1 ratio to receive once-weekly subcutaneous ecnoglutide injection or placebo, including a dose-escalation period, with the total treatment duration of up to 68 weeks, plus 5 weeks of follow-up period. The overall study will last for 73 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
subcutaneous injection
subcutaneous injection
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGChange in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Time frame: Baseline, week 68
Percentage Change in Body Weight
Time frame: Baseline, week 68
Percentage of Participants with ≥5% of Body Weight Loss
Time frame: Baseline, week 68
Percentage of Participants with ≥10% of Body Weight Loss
Time frame: Baseline, week 68
Percentage of Participants with ≥50% of Reduction in WOMAC Pain Subscale Score
Time frame: Baseline, week 68
Change in WOMAC Physical Function Subscale Score
Time frame: Baseline, week 68
Change in Short Form 36 (SF36) V2 Physical Function Subscale Score
Time frame: Baseline, week 68
Absolute Change in Body Weight
Time frame: Baseline, week 68
Percentage of Participants with ≥15% of Body Weight Loss
Time frame: Baseline, week 68
Change in WOMAC Total Score
Time frame: Baseline, week 68
Percentage of Participants with ≥50% of Reduction in WOMAC Physical Function Subscale Score
Time frame: Baseline, week 68
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Change in SF36V2 Score
Time frame: Baseline, week 68
Change in PGI-S Pain and Function Score of the Target Knee Joint
PGI-S stands for Patient Global Impressions Scale - Severity
Time frame: Baseline, week 68
Change in PGI-C Pain and Function Score of the Target Knee Joint
PGI-C stands for Patient Global Impressions Scale - Change
Time frame: Baseline, week 68
Change in Body Mass Index (BMI)
Time frame: Baseline, week 68
Change in Walking Distance During the 6-minute Walk Test
Time frame: Baseline, week 68
Percentage of Participants Using Allowed Analgesics During Wash Out
Time frame: Baseline, week 68
Amount of Allowed Analgesics Used During Wash Out
Amount of allowed analgesics used during wash out at end of treatment (week 68)is presented. Allowed analgesic during washout should be taken within 72 hour before the visit and prior to WOMAC assessment.
Time frame: Baseline, week 68
Percentage of Participants Using Analgesics
Time frame: Baseline, week 68
Change in Amount of Analgesics Used
Time frame: Baseline, week 68
Change in Lipid Profile
Include triglicerides, LDL-C, HDL-C, total cholesterol
Time frame: Baseline, week 68
Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline, week 68
Change in HbA1c
Time frame: Baseline, week 68
Change in Fasting Insulin
Time frame: Baseline, week 68
Change in Fasting C-peptide
Time frame: Baseline, week 68
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Baseline, week 68
Change in Blood Pressure
Time frame: Baseline, week 68
Adverse events
Time frame: Week 1 to week 73 (EOS)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
PHQ-9 questionnaire will be used to monitor status of mental health of the participants.
Time frame: Baseline to week 73 (EOS)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
C-SSRS questionnaire will be used to monitor status of mental health of the participants.
Time frame: Baseline to week 73 (EOS)
Change in Waist Circumference
Time frame: Baseline, week 68
Change in Hip Circumference
Time frame: Baseline, week 68
Change in Waist-to-hip Ratio
Time frame: Baseline, week 68
Trough Concentration of Ecnoglutide
Time frame: Week 1 to week 73 (EOS)