A Multicenter, Randomized, Double-blinded, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients
Overview
- Phase
- Phase 3
- Intervention
- Liraglutide
- Conditions
- Obese
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 414
- Locations
- 1
- Primary Endpoint
- The percentage of body weight loss
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect and safety of Liraglutide Injection on body weight loss compared with placebo in obese or overweight adult patients with comorbidity of metabolic disorders.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The total study duration is 34\~36 weeks, including 2-week screening period, 6\~8-week dosage titration, 24-week stable treatment and 2-week safety follow-up period. Subjects with obesity or overweight with comorbidity of metabolic disorders receive subcutaneous injection of 3.0 mg Liraglutide or placebo every day. The primary endpoint is the change of body weight or the percentage of body weight loss greater than 5%. The changes of body weight between Liraglutide Injection group and placebo group will be compared. In the course of the trial, the subjects are weighted on fasting state. Blood samples are collected according to the protocol. All subjects receive lifestyle intervention, including a reductiong of calorie intake by 500 kcal a day and physical exercise.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Those voluntarily participating and signing the ICF.
- •Those aged 18-70 years old (including 18 and 70 years old), without restriction on male and female
- •Those failing to control their body weight in previous diet therapy alone.
- •Those voluntarily following the medication, diet and exercise requirements decided by the investigators.
- •Those with a stable body weight (patient reported body weight change \< 5 kg) in last 3 months.
- •Those with BMI ≥ 30 kg/m2 (obese) or BMI ≥ 27 kg/m2 (overweight) accompanied by at least one treated or untreated related metabolic abnormality (hypertension, dyslipidemia, type 2 diabetes). Those with untreated hypertension defined as SBP ≥ 140 mmHg or DBP ≥ 90 mmHg; untreated dyslipidemia defined as LDL-C ≥ 4.1 mmol/L, TG ≥ 1.7 mmol/L, TC ≥ 5.7 mmol/L or HDL-C \< 1.0 mmol/L in male and \< 1.3 mmol/L in female.
- •Those with type 2 diabetes should additionally meet the following inclusion criteria:
- •Those diagnosed as type 2 diabetes according to WHO (1999) Diagnostic and Classification Criteria at the time of screening;
- •Those receiving diet and exercise therapy alone, or receivig metformin, sulfonylureas, glycosidase inhibitors and glinides alone or in combination on the basis of diet and exercise therapy, with their treatment remaining stable at least 3 months before screening (with original documents such as prescriptions provided);
- •Those with HbA1c of 7.0-10.0% (inclusive);
Exclusion Criteria
- •Subjects who meet one of the following exclusion criteria will be excluded.
- •Those with type 1 diabetes or secondary diabetes.
- •Those with acute metabolic complications such as diabetic ketoacidosis or hyperglycemia (coma) within 6 months before screening.
- •Those with 2 or more severe hypoglycemia events (hypoglycemia with severe cognitive impairment and need other measures to help them recover) without obvious inducement within 3 months before screening.
- •Those receiving GLP-1 receptor agonist, DPP-4 inhibitors, SGLT-2 inhibitor, or insulin therapy within 3 months prior to screening.
- •Those with obesity caused by endocrine diseases such as Cushing's syndrome.
- •Patients taking drugs that can significantly increase weight in the 3 months before screening, including systemic glucocorticoid (except cumulative or continuous use of less than 14 days).
- •Those using OTC weight-loss drugs or appetite inhibitors (including traditional Chinese medicine as weight-loss drugs) within 1 month before screening, or use prescription weight-loss drugs (such as fentanyl, sibutramine, orlistat) or lipid dissolving injection (such as fat dissolving needle) within 3 months before screening.
- •Those with binge eating behavior in the past, that is, eating a large amount of food in a short period of time with a sense of loss of control.
- •Those who have treated or plan to treat obesity (during the trial) with surgery or body weight loss devices.
Arms & Interventions
Liraglutide
Liraglutide Injection, once a day, injected subcutaneously on abdomen, thigh or upper arm.
Intervention: Liraglutide
Placebo
Placebo (Liraglutide Injection simulator), once a day, injected subcutaneously on abdomen, thigh or upper arm.
Intervention: Placebo
Outcomes
Primary Outcomes
The percentage of body weight loss
Time Frame: through study completion, an average of 32 weeks
The percentage of body weight loss from baseline to the end of treatment
The proportion of body weight loss ≥ 5 percent
Time Frame: through study completion, an average of 32 weeks
The proportion of subjects whose body weight loss is greater than ≥ 5 percent from baseline level to the end of treatment
Secondary Outcomes
- Changes in waist circumference(through study completion, an average of 32 weeks)
- Changes in diastolic pressure and systolic pressure(through study completion, an average of 32 weeks)
- Changes in pulse of the subjects(through study completion, an average of 32 weeks)
- Absolute body weight change(through study completion, an average of 32 weeks)
- The proportion of body weight loss > 10 percent(through study completion, an average of 32 weeks)
- The changes in IWQOL-lite(through study completion, an average of 32 weeks)
- The changes in HbA1c(through study completion, an average of 32 weeks)
- The changes in blood lipid(through study completion, an average of 32 weeks)
- The changes in blood glucose(through study completion, an average of 32 weeks)