Obesity
Conditions
Keywords
Obesity, Weight loss, lorcaserin, APD356, BLOOM, Hypertension, Dyslipidemia, Sleep apnea, glucose tolerance, cardiovascular disease, Arena
Brief summary
The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104)
Interventions
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks.
Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Obese adults with a BMI 30 to 45 kg/m2 or overweight adults with a BMI 27 to 29.9 kg/m2 and at least one obesity-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, glucose intolerance, sleep apnea) * Ability to complete a 2 year study
Exclusion criteria
* Diabetes * Pregnancy * History of heart valve disease * Serious or unstable current or past medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 | 104 weeks | The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2. |
| Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 | 52 weeks | The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Year 1: Percent Change in Body Weight From Baseline to Week 52 | 52 weeks | Year 1: The % change in body weight (kg) from baseline to week 52. |
| Year 2: Percent Change in Body Weight From Week 52 to Week 104 | 52 weeks | Year 2: The % change in body weight (kg) from week 52 to week 104. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Year 1 - Lorcaserin 10 mg BID lorcaserin 10 mg BID tablets | 1,593 |
| Year 1 - Matching Placebo BID matching placebo tablets | 1,584 |
| Total | 3,177 |
Baseline characteristics
| Characteristic | Year 1 - Lorcaserin 10 mg BID | Year 1 - Matching Placebo BID | Total |
|---|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 11.32 | 44.4 years STANDARD_DEVIATION 11.11 | 44.1 years STANDARD_DEVIATION 11.22 |
| Sex: Female, Male Female | 1321 Participants | 1331 Participants | 2652 Participants |
| Sex: Female, Male Male | 272 Participants | 253 Participants | 525 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1,324 / 1,593 | 1,203 / 1,584 | 450 / 573 | 210 / 283 | 515 / 697 |
| serious Total, serious adverse events | 38 / 1,593 | 37 / 1,584 | 15 / 573 | 6 / 283 | 24 / 697 |
Outcome results
Primary
Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52
The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1. Other co-primary endpoints are change from baseline in body weight (kg) at year 1 and the proportion of patients achieving ≥ 10% reduction in body weight at year 1.
Time frame: 52 weeks
Population: MITT with LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lorcaserin 10 mg BID | Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 | 47.5 percentage of participants |
| Matching Placebo BID | Year 1: Co-Primary Endpoint- Proportion (%) of Patients Achieving > or = 5% Weight Loss From Baseline to Week 52 | 20.3 percentage of participants |
p-value: <0.000195% CI: [3, 4.2]ANCOVA
Primary
Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104
The proportion of patients with a reduction from baseline body weight of 5% or more at the end of year 1 and who maintained this reduction during year 2.
Time frame: 104 weeks
Population: MITT with LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lorcaserin 10 mg BID | Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 | 67.9 percentage of participants |
| Matching Placebo BID | Year 2: Proportion (%) of Patients Maintaining > or = 5% Weight Loss at Week 104 | 50.3 percentage of participants |
Secondary
Year 1: Percent Change in Body Weight From Baseline to Week 52
Year 1: The % change in body weight (kg) from baseline to week 52.
Time frame: 52 weeks
Population: MITT with LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lorcaserin 10 mg BID | Year 1: Percent Change in Body Weight From Baseline to Week 52 | -5.87 % change from baseline: body wt (kg) | Standard Error 0.18 |
| Matching Placebo BID | Year 1: Percent Change in Body Weight From Baseline to Week 52 | -2.20 % change from baseline: body wt (kg) | Standard Error 0.18 |
p-value: <0.00195% CI: [-4.09, -3.25]ANCOVA
Secondary
Year 2: Percent Change in Body Weight From Week 52 to Week 104
Year 2: The % change in body weight (kg) from week 52 to week 104.
Time frame: 52 weeks
Population: MITT with LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lorcaserin 10 mg BID | Year 2: Percent Change in Body Weight From Week 52 to Week 104 | 2.79 % change from baseline: body wt (kg) | Standard Error 0.23 |
| Matching Placebo BID | Year 2: Percent Change in Body Weight From Week 52 to Week 104 | 5.38 % change from baseline: body wt (kg) | Standard Error 0.31 |
| Placebo (Yr 1) / Placebo (Yr 2) | Year 2: Percent Change in Body Weight From Week 52 to Week 104 | 1.15 % change from baseline: body wt (kg) | Standard Error 0.22 |
p-value: <0.00195% CI: [-3.29, -1.88]ANCOVA
p-value: <0.00195% CI: [1.1, 2.19]ANCOVA