Obesity
Conditions
Keywords
obesity, weight loss, lorcaserin, APD356, BLOOM-DM, 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 during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.
Interventions
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
DRUGMatching Placebo
Matching placebo tablet each morning and evening for a duration of 52 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
* Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s). * Body mass index (BMI) 27 to 45 kg/m2, inclusive. * Ability to complete a 1 year study
Exclusion criteria
* Pregnancy * Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening * History of symptomatic heart valve disease * Serious or unstable current or past medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | Baseline and Week 52 | The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Body Weight From Baseline to Week 52 | Baseline and Week 52 | The percent change in body weight (kg) from baseline to week 52. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lorcaserin 10 mg QD lorcaserin 10 mg QD tablets | 95 |
| Lorcaserin 10 mg BID lorcaserin 10 mg BID tablets | 256 |
| Matching Placebo matching placebo tablets | 252 |
| Total | 603 |
Baseline characteristics
| Characteristic | Lorcaserin 10 mg QD | Lorcaserin 10 mg BID | Matching Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 7.98 | 53.2 years STANDARD_DEVIATION 8.26 | 52.0 years STANDARD_DEVIATION 9.32 | 52.7 years STANDARD_DEVIATION 8.68 |
| Sex: Female, Male Female | 53 Participants | 137 Participants | 137 Participants | 327 Participants |
| Sex: Female, Male Male | 42 Participants | 119 Participants | 115 Participants | 276 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 236 / 256 | 89 / 95 | 213 / 252 |
| serious Total, serious adverse events | 16 / 256 | 8 / 95 | 17 / 252 |
Outcome results
Primary
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
Time frame: Baseline and Week 52
Population: Modified Intent to Treat (MITT) with last observation carried forward (LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lorcaserin 10 mg BID | Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | 37.5 percentage of participants |
| Lorcaserin 10 mg QD | Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | 44.7 percentage of participants |
| Matching Placebo | Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 | 16.1 percentage of participants |
p-value: <0.000195% CI: [2.05, 4.8]Regression, Logistic
Secondary
Percent Change in Body Weight From Baseline to Week 52
The percent change in body weight (kg) from baseline to week 52.
Time frame: Baseline and Week 52
Population: MITT with LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lorcaserin 10 mg BID | Percent Change in Body Weight From Baseline to Week 52 | -4.54 % change from baseline: body wt (kg) | Standard Error 0.35 |
| Lorcaserin 10 mg QD | Percent Change in Body Weight From Baseline to Week 52 | -4.97 % change from baseline: body wt (kg) | Standard Error 0.54 |
| Matching Placebo | Percent Change in Body Weight From Baseline to Week 52 | -1.48 % change from baseline: body wt (kg) | Standard Error 0.36 |
p-value: <0.000195% CI: [-3.92, -2.2]ANCOVA