Obese, Overweight
Conditions
Keywords
weight loss, obeses, overwweight, Liraglutide
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.
Interventions
DRUGLiraglutide
Liraglutide Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Liraglutide Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.
DRUGPlacebo
Placebo Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Placebo Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Regardless of treatment allocations, each subject receive the same total volume of investigational drug or placebo. All drug automatic injectors and kits, study drugs or placebo are identical in appearance and labels to blind subjects and investigators. This can minimize the bias of investigators and subjects on treatment evaluation.
Intervention model 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, 6\ 8-week dosage titration, 24-week stable treatment and 2-week safety follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Those voluntarily participating and signing the ICF. 2. Those aged 18-70 years old (including 18 and 70 years old), without restriction on male and female 3. Those failing to control their body weight in previous diet therapy alone. 4. Those voluntarily following the medication, diet and exercise requirements decided by the investigators. 5. Those with a stable body weight (patient reported body weight change \< 5 kg) in last 3 months. 6. 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. 7. Those with type 2 diabetes should additionally meet the following inclusion criteria: 1. Those diagnosed as type 2 diabetes according to WHO (1999) Diagnostic and Classification Criteria at the time of screening; 2. 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); 3. Those with HbA1c of 7.0-10.0% (inclusive); 4. Those with FPG \< 13.3 mmol/L (240 mg/dL).
Exclusion criteria
Subjects who meet one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of body weight loss | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| The changes in blood glucose | through study completion, an average of 32 weeks | The change in fasting blood-glucose of the subjects at the end of treatment |
| The changes in blood lipid | through study completion, an average of 32 weeks | The changes in blood lipid levels (triglyceride, total cholesterol, low density lipoprotein cholesterol, and high density lipoprotein cholesterol) of the subjects at the end of treatment |
| Changes in waist circumference | through study completion, an average of 32 weeks | Changes in waist circumference of the subjects at the end of treatment |
| Changes in diastolic pressure and systolic pressure | through study completion, an average of 32 weeks | Changes in blood pressure level (diastolic pressure and systolic pressure) of the subjects at the end of treatment |
| Absolute body weight change | through study completion, an average of 32 weeks | The absolute body weight loss of the subjects at the end of treatment |
| The proportion of body weight loss > 10 percent | through study completion, an average of 32 weeks | The proportion of subjects with body weight loss \> 10 percent at the end of treatment |
| The changes in IWQOL-lite | through study completion, an average of 32 weeks | Effect of changes in body weight of the patients to the IWQOL-lite at the end of treatment |
| The changes in HbA1c | through study completion, an average of 32 weeks | The changes in HbA1c of patients with type 2 diabetes at the end of treatment |
| Changes in pulse of the subjects | through study completion, an average of 32 weeks | Changes in pulse of the subjects at the end of treatment |
Countries
China
Outcome results
None listed