Clinical trial NCT03720574: Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients
Official title: Efficacy and Safety of Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Adult Obese Patients: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Keywords: Overweight or Obesity Management
Behavioral Modification
Lead sponsor: Kanion & Huawe Medicine Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2018-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and weight loss effect of lorcaserin at the end of the first year of treatment (Week 48) in overweight and Chinese adult obese patients compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Males or females aged from 18 to 65 years (inclusive).
* Able to walk and preform exercise program required by trial protocol.
* Body Mass Index (BMI) within the range of 30 to 45 kg/m2 (obese) with or without co-morbid conditions or greater than or equal to 27 and less than 30 kg/m2 (overweight) with at least one treated or untreated comorbid condition (hypertension, dyslipidemia, cardiovascular disease, untreated abnormal glucose metabolism, sleep apnea). For untreated co-morbid conditions, the condition must be considered by the Investigator as clinically stable.
* Prior to the study, patients should be able to voluntarily participate in this study and sign informed consent form approved by IRB/ICE

Exclusion Criteria:

* Not suitable to participate in the study in the opinion of the Investigator, including an existing physical or mental condition that prevents compliance with the protocol.
* Patients who had a history of Type 1 diabetes mellitus or confirmed diagnosis of Type 2 diabetes mellitus for more than 6 months.
* Recent history (within 1 years before entering the study) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication (e.g., SSRI's, SNRI's \[including buproprion\], tricyclics, antipsychotics, lithium). Use of SSRI's and SNRI's (including buproprion) for reasons other than active psychiatric indications (e.g., migraine, weight loss, smoking cessation) must meet a 3-month washout.
* Total score on the Beck Depression Inventory-II (BDI-II) \> 20.
* Binge Eating Scale score \>17.
* History of epilepsy or other seizure disorder.
* Has done or anticipate Surgical procedure for the treatment of obesity (i.e., gastric bypass, gastric banding).
* Anticipation of surgery during the study period that may interfere with completion or compliance with the protocol.
* Uncontrolled hypertension after certain treatments, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg.
* History of valve replacement surgery or CABG or other invasive cardiovascular surgical procedure. A diagnostic cardiac catheterization does not exclude.
* History of Myocardial infarction(MI), Cerebral Vascular Accident(CVA), or transient ischemic attack(TIA). Reversible ischemic neurological deficits (RIND), cardiac arrhythmia requiring medical or surgical treatment within 3 months of screening.
* Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of screening
* History of unstable angina
* History of congestive heart failure caused by insufficiency or stenosis of any heart valve
* History of pulmonary artery hypertension
* Symptomatic untreated congestive heart failure of any etiology (stably treated NYHA class I or II CHF of ischemic or hypertensive etiology is acceptable)
* History of organ/bone marrow transplantation
* Abnormal TSH lab value \> 1.5x ULN
* Hyperthyroidism, including abnormal screening lab values with FT4 \> ULN and TSH \< LLN.
* Fasting triglycerides \> 499 mg/dL(5.64 mmol/L) ,if elevated at Screening, but not on a subsequent re-check, patient will be eligible. Otherwise, patients can't be enrolled.
* LDL-cholesterol ≥ 190 mg/dL(4.92 mmol/L).
* HbA1c greater than 9.0%
* Fasting glucose \> 270 mg/dL(11.0 mmol/L) ,if elevated at Screening, but not on a subsequent re-check, patient will be eligible. Otherwise, patients can't be enrolled.
* Clinically significant abnormal hepatic (e.g., AST or ALT \> 2.5x ULN, or total bilirubin \> 1.5x ULN) or renal function lab tests (e.g., creatinine \> 1.25x ULN) suggestive of hepatic or renal impairment.
* Positive result of HIV, hepatitis B or hepatitis C screens.
* Malignancy within 5 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins).
* Treatment with over-the counter weight loss products or appetite suppressants (including herbal weight loss agents) within 1 month of the screening visit, or with a prescription anti-obesity drug (phentermine, sibutramine, orlistat) or lipid dissolving injections within 3 months.
* Over 3 days of treatment with oral or parenteral corticosteroids within 2 weeks of the screening visit.
* Recent history (within 2 years prior to the screening visit) of alcohol or drug abuse.
* Significant change in smoking habits within 3 months prior to screening.
* Participated in any clinical study with an investigational drug, biologic, or device within 3 month prior to screening.
* Significant change in diet or level of physical activity or change in weight of \> 5 kg within 3 month prior to screening.
* Use of liquid weight loss diet within 6 months prior to screening.
* Disagree to continue to use an accepted method of birth control during and for at least 3 months after last study medication administration.

Primary outcomes:
measure: 5% responders
timeFrame: 48 weeks
Secondary outcomes:
measure: Weight change
timeFrame: 48 weeks
measure: 10% responders
timeFrame: 48 weeks
measure: circumference and hip circumference change
timeFrame: 48 weeks
measure: Blood Pressure change
timeFrame: 48 weeks
measure: Lipids change
timeFrame: 48 weeks
measure: CV Risk Markers change
timeFrame: 48 weeks
measure: Glucose and HbA1c change
timeFrame: 48 weeks
measure: IWQOL-LITE score change
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Bengbu
country: China
facility: Bengbu Medical College First Affiliated Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
city: Changzhou
country: China
facility: Second Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Jinzhou
country: China
facility: Jinzhou Central Hospital
state: Liaoning
city: Jinan
country: China
facility: Jinan Center Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Peking University First Hospital
name: Xiaohui Guo, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: