Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients

NCT03720574 | Terminated Phase 3

• 1 other identifier: LWY17016C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Obesity

Keywords

Overweight or Obesity Management; Behavioral Modification

Outcome Measures

Primary Outcomes (1)

• 5% responders

  Proportion (%) of subjects who lose at least 5% of their baseline body weight at week 48

  48 weeks

Secondary Outcomes (8)

• Weight change

  48 weeks

• 10% responders

  48 weeks

• circumference and hip circumference change

  48 weeks

• Blood Pressure change

  48 weeks

• Lipids change

  48 weeks

Study Arms (2)

Lorcaserin 10 mg BID

EXPERIMENTAL

Lorcaserin 10 mg tablet each morning and evening

Drug: Lorcaserin 10 mg BID

Matching Placebo BID

PLACEBO COMPARATOR

Matching Placebo tablet each morning and evening

Drug: Matching Placebo BID

Interventions

Lorcaserin 10 mg BID DRUG

Lorcaserin 10 mg tablet each morning and evening for a duration of 48 weeks

Lorcaserin 10 mg BID

Matching Placebo BID DRUG

Matching Placebo tablet each morning and evening for a duration of 48 weeks

Matching Placebo BID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanion & Huawe Medicine Co.,Ltd: lead

Study Sites (9)

Bengbu Medical College First Affiliated Hospital

Bengbu, Anhui, 233000, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

Xiangtan Central Hospital

Xiangtan, Hunan, 411100, China

Location

Second Hospital of Changzhou

Changzhou, Jiangsu, 213119, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Jinzhou Central Hospital

Jinzhou, Liaoning, 121000, China

Location

Jinan Center Hospital

Jinan, Shandong, 250013, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

lorcaserin; BID protein, human

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaohui Guo, Ph. D

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 25, 2018
• Study Start: September 17, 2019
• Primary Completion: December 6, 2020
• Study Completion: December 12, 2020
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)