ObesityPhase 3NCT03720574
Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients
A Phase 3 study testing Lorcaserin 10 mg BID in people with Obesity, run by Kanion & Huawe Medicine Co.,Ltd at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lorcaserin 10 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 9 sitesChina
- Study dates
- 17 Sep 2019to 12 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Bengbu Medical College First Affiliated Hospital
Bengbu, Anhui, 233000
Second Hospital of Changzhou
Changzhou, Jiangsu, 213119
Jinan Center Hospital
Jinan, Shandong, 250013
Jinzhou Central Hospital
Jinzhou, Liaoning, 121000
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Shanghai East Hospital
Shanghai, Shanghai Municipality
Xiangtan Central Hospital
Xiangtan, Hunan, 411100
About this study
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
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
- Being tested
- Lorcaserin 10 mg BID, Matching Placebo BID
- Keywords
- Overweight or Obesity Management, Behavioral Modification
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lorcaserin 10 mg BIDDrug
Lorcaserin 10 mg tablet each morning and evening for a duration of 48 weeks
Matching Placebo BIDDrug
Matching Placebo tablet each morning and evening for a duration of 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lorcaserin 10 mg BID | Experimental | Lorcaserin 10 mg tablet each morning and evening Receives: Drug: Lorcaserin 10 mg BID |
| Matching Placebo BID | Placebo comparator | Matching Placebo tablet each morning and evening Receives: Drug: Matching Placebo BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
5% responders
Proportion (%) of subjects who lose at least 5% of their baseline body weight at week 48
Measured: 48 weeks
Secondary outcomes (8)
Weight change
Change from baseline in body weight (kilograms) at week 48
Measured: 48 weeks
10% responders
Proportion (%) of subjects who lose at least 10% of their baseline body weight at week 48
Measured: 48 weeks
circumference and hip circumference change
Change from baseline in waist circumference and hip circumference (centimeters) at week 48
Measured: 48 weeks
Blood Pressure change
Change from baseline in waist systolic/ diastolic blood pressure (mmHg) at week 48
Measured: 48 weeks
Lipids change
Change from baseline in Lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) (mmol/L) at week 48
Measured: 48 weeks
CV Risk Markers change
Change from baseline in CV Risk Markers (CRP in μg/L, fibrinogen in g/L) at week 48
Measured: 48 weeks
Glucose and HbA1c change
Change from baseline in fasting glucose (mmol/L) and HbA1c (%) at week 48
Measured: 48 weeks
IWQOL-LITE score change
Change from baseline in IWQOL-LITE score at week 48
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start17 Sep 2019
- Primary completion6 Dec 2020
- Study completion12 Dec 2020
Why it stopped: Reassess safety risks and benefits
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanion & Huawe Medicine Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaohui Guo, Ph. D, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720574
- Sponsor's protocol ID
- LWY17016C
- Status last verified
- Apr 2022
- First submitted
- 24 Oct 2018
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03720574
- Acronym / sponsor ID
- LWY17016C
- Conditions
- Obesity
- Keywords
- Overweight or Obesity Management, Behavioral Modification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reassess safety risks and benefits
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kanion & Huawe Medicine Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorcaserin 10 mg BID | Experimental | Drug: Lorcaserin 10 mg BIDLorcaserin 10 mg tablet each morning and evening |
| Matching Placebo BID | Placebo comparator | Drug: Matching Placebo BIDMatching Placebo tablet each morning and evening |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lorcaserin 10 mg BIDLorcaserin 10 mg tablet each morning and evening for a duration of 48 weeks | Drug | Lorcaserin 10 mg BID |
| Matching Placebo BIDMatching Placebo tablet each morning and evening for a duration of 48 weeks | Drug | Matching Placebo BID |
Primary outcome
5% responders
Time frame: 48 weeks
Proportion (%) of subjects who lose at least 5% of their baseline body weight at week 48
8 secondary outcomes
Weight change
Time frame: 48 weeks
10% responders
Time frame: 48 weeks
circumference and hip circumference change
Time frame: 48 weeks
Blood Pressure change
Time frame: 48 weeks
Lipids change
Time frame: 48 weeks
CV Risk Markers change
Time frame: 48 weeks
Glucose and HbA1c change
Time frame: 48 weeks
IWQOL-LITE score change
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: Reassess safety risks and benefits). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohui Guo, Ph. D principal investigator
Peking University First Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lorcaserin 10 mg BID in people with Obesity, run by Kanion & Huawe Medicine Co.,Ltd at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Reassess safety risks and benefits). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5% responders (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.