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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02019264




Registration number
NCT02019264
Ethics application status
Date submitted
18/12/2013
Date registered
24/12/2013
Date last updated
16/07/2019

Titles & IDs
Public title
A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
Secondary ID [1] 0 0
2013-000324-34
Secondary ID [2] 0 0
APD356-G000-401
Universal Trial Number (UTN)
Trial acronym
CAMELLIA-TIMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
High Cardiovascular Risk 0 0
Obesity 0 0
Overweight 0 0
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lorcaserin hydrochloride
Treatment: Drugs - Placebo

Experimental: Lorcaserin hydrochloride (HCL)10 mg - APD356 10 mg twice daily

Placebo comparator: Placebo - Placebo twice daily


Treatment: Drugs: Lorcaserin hydrochloride
APD356 10 mg twice daily

Treatment: Drugs: Placebo
Placebo twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis
Timepoint [1] 0 0
Baseline up to Month 42
Primary outcome [2] 0 0
Time From Randomization to First Occurrence of MACE+
Timepoint [2] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [1] 0 0
Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline
Timepoint [1] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [2] 0 0
Time From Randomization to First Occurrence of the Individual Components of MACE+
Timepoint [2] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [3] 0 0
Time From Randomization to Event of All-cause Mortality
Timepoint [3] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [4] 0 0
Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline
Timepoint [4] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [5] 0 0
Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline
Timepoint [5] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [6] 0 0
Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline
Timepoint [6] 0 0
Baseline, and Month 6
Secondary outcome [7] 0 0
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants
Timepoint [7] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [8] 0 0
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline
Timepoint [8] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [9] 0 0
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline
Timepoint [9] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [10] 0 0
Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline
Timepoint [10] 0 0
Baseline up to end of study (Month 56)
Secondary outcome [11] 0 0
Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes
Timepoint [11] 0 0
Months 6 and 12
Secondary outcome [12] 0 0
Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy
Timepoint [12] 0 0
Months 6 and 12
Secondary outcome [13] 0 0
Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure
Timepoint [13] 0 0
Baseline, Month 12

Eligibility
Key inclusion criteria
Inclusion Criteria

1. BMI greater than or equal (>=) to 27 kilogram per meter square (kg/m^2)
2. Subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program
3. Age >= to 40 years with established CV disease as defined by one of the following:

1. History of documented MI or ischemic stroke
2. History of peripheral artery disease
3. History of revascularization (coronary, carotid, or peripheral artery)
4. Significant unrevascularized coronary arterial stenosis

OR

Age >= to 55 years for women or >= to 50 years for men who have type 2 diabetes mellitus (T2DM) without established CV disease plus at least one of the following CV risk factors:

1. Hypertension, or currently receiving therapy for documented hypertension
2. Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia
3. Estimated glomerular filtration rate >= to 30 to less than equal (<=) to 60 mililitre per minute per 1.73 meter square (mL/min/1.73 m^) per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
4. High high sensitivity C-reactive protein (hsCRP)
5. Urinary albumin-to-creatinine ratio (ACR) >= 30 ug/mg

Subjects with T2DM may have a pre-existing or new diagnosis of T2DM. A new diagnosis of T2DM (ie, discovered at Screening) should be based on the 2013 American Diabetes Association (ADA) guidelines.

All T2DM subjects must have an HbA[1c] less (<) than 10% at Screening. If subjects are being treated, or upon diagnosis need to be treated with antidiabetic agents, the T2DM treatment regimen must be stable for at least 3 months prior to randomization.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Moderate or greater symptoms of congestive cardiac failure (New York Heart Association [NYHA] class III or IV)
2. Known left ventricular (LV) ejection fraction < than 20%
3. Moderate or greater symptoms of pulmonary hypertension (PH)
4. Known severe valvular disease
5. Moderate renal impairment, severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m^ per the CKD-EPI equation based on ideal body weight), or end stage renal disease (ESRD)
6. Severe hepatic impairment
7. Use of other products intended for weight loss including prescription drugs, over-the-counter (OTC) drugs, and herbal preparations
8. Use of more than one other serotonergic drug
9. Use of drugs known to increase the risk for cardiac valvulopathy within 6 months prior to Screening including, but not limited to: pergolide, ergotamine, methysergide, cabergoline
10. History or evidence of clinically significant disease (e.g., malignancy, cardiac, respiratory, gastrointestinal, renal or psychiatric disease)
11. Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any of the excipients
12. Planned bariatric surgery
13. Females must not be breastfeeding or pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/05/2018
Sample size
Target
Accrual to date
Final
14673
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [2] 0 0
Gosford Hospital, Cardiology Clinical Trials - Gosford
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Illawarra Shoalhaven Local Health District, Clinical Trial and Research Unit - Wollongong
Recruitment hospital [5] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [6] 0 0
Core Research Group - Brisbane
Recruitment hospital [7] 0 0
Princess Alexandra Hospital, Cardiology Research Department - Brisbane
Recruitment hospital [8] 0 0
Royal Brisbane and Women's Hospital, Endocrinology Department - Herston
Recruitment hospital [9] 0 0
HeartCare Partners Clinical Research Unit - Milton
Recruitment hospital [10] 0 0
AusTrials Pty Ltd - Sherwood
Recruitment hospital [11] 0 0
Gold Coast Hospital, Cardiovascular Research Centre - Southport
Recruitment hospital [12] 0 0
New Royal Adelaide Hospital, Cardiology Department - Adelaide
Recruitment hospital [13] 0 0
Adelaide Medical Research - Ashford
Recruitment hospital [14] 0 0
Lyell McEwin Hospital, Department of Cardiology - Elizabeth Vale
Recruitment hospital [15] 0 0
Heart and Vascular Institute - Fullarton
Recruitment hospital [16] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [17] 0 0
Ballarat Health Services - Ballarat
Recruitment hospital [18] 0 0
Geelong Cardiology Research Unit, Barwon Health - Geelong
Recruitment hospital [19] 0 0
Austin Health - Heidelberg Repatriation Hospital, Department of Medicine, Boronia Centre - Heidelberg Heights
Recruitment hospital [20] 0 0
Avenue Cardiovascular Centre - Saint Kilda East
Recruitment hospital [21] 0 0
Joondalup Cardiovascular Trials Foundation Inc - Joondalup
Recruitment hospital [22] 0 0
Fiona Stanley Hospital, Cardiology Research Department,CDO11 - Murdoch
Recruitment hospital [23] 0 0
South Australian Medical Research Inst, Centre for Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4064 - Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4064 - Milton
Recruitment postcode(s) [9] 0 0
4075 - Sherwood
Recruitment postcode(s) [10] 0 0
4215 - Southport
Recruitment postcode(s) [11] 0 0
5000 - Adelaide
Recruitment postcode(s) [12] 0 0
5035 - Ashford
Recruitment postcode(s) [13] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [14] 0 0
SA 5063 - Fullarton
Recruitment postcode(s) [15] 0 0
5011 - Woodville South
Recruitment postcode(s) [16] 0 0
3353 - Ballarat
Recruitment postcode(s) [17] 0 0
3220 - Geelong
Recruitment postcode(s) [18] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [19] 0 0
3183 - Saint Kilda East
Recruitment postcode(s) [20] 0 0
6027 - Joondalup
Recruitment postcode(s) [21] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Alaska
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Arkansas
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Colorado
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Connecticut
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Delaware
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Tauranga
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Bezrzecze
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Biala Rawska
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Bialystok
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Bydgoszcz
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Chorzów
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Chrzanów
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Gdynia
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Inowroclaw
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Kamieniec Zabkowicki
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Koluszki
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Kraków
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Legnica
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Lublin
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Mragowo
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Torun
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Wroclaw
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Lódz
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Leczna

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Thrombolysis In Myocardial Infarction (TIMI) Academic Research Organization
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.
Trial website
https://clinicaltrials.gov/study/NCT02019264
Trial related presentations / publications
Scirica BM, Bohula EA, Dwyer JP, Qamar A, Inzucchi SE, McGuire DK, Keech AC, Smith SR, Murphy SA, Im K, Leiter LA, Gupta M, Patel T, Miao W, Perdomo C, Bonaca MP, Ruff CT, Sabatine MS, Wiviott SD; CAMELLIA-TIMI 61 Steering Committee and Investigators. Lorcaserin and Renal Outcomes in Obese and Overweight Patients in the CAMELLIA-TIMI 61 Trial. Circulation. 2019 Jan 15;139(3):366-375. doi: 10.1161/CIRCULATIONAHA.118.038341.
Bohula EA, Scirica BM, Inzucchi SE, McGuire DK, Keech AC, Smith SR, Kanevsky E, Murphy SA, Leiter LA, Dwyer JP, Corbalan R, Hamm C, Kaplan L, Nicolau JC, Ophuis TO, Ray KK, Ruda M, Spinar J, Patel T, Miao W, Perdomo C, Francis B, Dhadda S, Bonaca MP, Ruff CT, Sabatine MS, Wiviott SD; CAMELLIA-TIMI 61 Steering Committee Investigators. Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial. Lancet. 2018 Nov 24;392(10161):2269-2279. doi: 10.1016/S0140-6736(18)32328-6. Epub 2018 Oct 4.
Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, Fanola CL, Qamar A, Brown C, Budaj A, Garcia-Castillo A, Gupta M, Leiter LA, Weissman NJ, White HD, Patel T, Francis B, Miao W, Perdomo C, Dhadda S, Bonaca MP, Ruff CT, Keech AC, Smith SR, Sabatine MS, Scirica BM; CAMELLIA-TIMI 61 Steering Committee and Investigators. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. N Engl J Med. 2018 Sep 20;379(12):1107-1117. doi: 10.1056/NEJMoa1808721. Epub 2018 Aug 26.
Bohula EA, Scirica BM, Fanola C, Inzucchi SE, Keech A, McGuire DK, Smith SR, Abrahamsen T, Francis BH, Miao W, Perdomo CA, Satlin A, Wiviott SD, Sabatine MS. Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial. Am Heart J. 2018 Aug;202:39-48. doi: 10.1016/j.ahj.2018.03.012. Epub 2018 Mar 29.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02019264