ObesityPhase 3NCT00603291
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
A Phase 3 study testing Lorcaserin 10 mg once daily (QD) and Lorcaserin 10 mg twice a day (BID) in people with Obesity, run by Eisai Inc. at 1 site in United States.
Trial 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. 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 once daily (QD) and Lorcaserin 10 mg twice a day (BID)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 604 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Oct 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arena Pharmaceuticals, Inc.
San Diego, California, 92121
About this study
Official title: A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients With Type 2 Diabetes Mellitus Managed With Oral Hypoglycemic Agent(s)
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.
- Conditions
- Obesity
- Being tested
- Lorcaserin 10 mg once daily (QD), Lorcaserin 10 mg twice a day (BID), Matching Placebo
- Keywords
- obesity, weight loss, lorcaserin, APD356, BLOOM-DM, hypertension, dyslipidemia, sleep apnea, glucose tolerance, cardiovascular disease, Arena
- Medical subject headings
- Obesity, Weight Loss, Hypertension, Dyslipidemias, Sleep Apnea Syndromes, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lorcaserin 10 mg once daily (QD)Drug
Also called APD356
Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.
Lorcaserin 10 mg twice a day (BID)Drug
Also called APD356
Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.
Matching PlaceboDrug
Matching placebo tablet each morning and evening for a duration of 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lorcaserin 10 mg QD | Experimental | Lorcaserin 10 mg tablet each morning and placebo tablet each evening Receives: Drug: Lorcaserin 10 mg once daily (QD) |
| Lorcaserin 10 mg BID | Experimental | Lorcaserin 10 mg tablet each morning and evening Receives: Drug: Lorcaserin 10 mg twice a day (BID) |
| Matching Placebo | Placebo comparator | Matching placebo tablet each morning and evening Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 52
Secondary outcomes (1)
Percent Change in Body Weight From Baseline to Week 52
The percent change in body weight (kg) from baseline to week 52.
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603291
- Sponsor's protocol ID
- APD356-010
- Status last verified
- Aug 2019
- First submitted
- 17 Jan 2008
- Last updated
- 2 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Magkos F, Nikonova E, Fain R, Zhou S, Ma T, Shanahan W. Effect of lorcaserin on glycemic parameters in patients with type 2 diabetes mellitus. Obesity (Silver Spring). 2017 May;25(5):842-849. doi: 10.1002/oby.21798. Epub 2017 Mar 27.
PubMed 28345809Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26.
PubMed 27888609Handelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19.
PubMed 27659698Pi-Sunyer X, Shanahan W, Fain R, Ma T, Garvey WT. Impact of lorcaserin on glycemic control in overweight and obese patients with type 2 diabetes: analysis of week 52 responders and nonresponders. Postgrad Med. 2016 Aug;128(6):591-7. doi: 10.1080/00325481.2016.1208618. Epub 2016 Jul 18.
PubMed 27389084Nguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17.
PubMed 27206567Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9.
PubMed 23661689O'Neil PM, Smith SR, Weissman NJ, Fidler MC, Sanchez M, Zhang J, Raether B, Anderson CM, Shanahan WR. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity (Silver Spring). 2012 Jul;20(7):1426-36. doi: 10.1038/oby.2012.66. Epub 2012 Mar 16.
PubMed 22421927
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients With Type 2 Diabetes Mellitus Managed With Oral Hypoglycemic Agent(s)
- ClinicalTrials.gov ID
- NCT00603291
- Acronym / sponsor ID
- APD356-010
- Conditions
- Obesity
- Keywords
- obesity, weight loss, lorcaserin, APD356, BLOOM-DM, hypertension, dyslipidemia, sleep apnea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Jan 2008 (estimated)
- Results
- Posted 7 Feb 2013
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lorcaserin 10 mg QD | Experimental | Drug: Lorcaserin 10 mg once daily (QD)Lorcaserin 10 mg tablet each morning and placebo tablet each evening |
| Lorcaserin 10 mg BID | Experimental | Drug: Lorcaserin 10 mg twice a day (BID)Lorcaserin 10 mg tablet each morning and evening |
| Matching Placebo | Placebo comparator | Drug: Matching PlaceboMatching 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 (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 once daily (QD)Also: APD356Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks. | Drug | Lorcaserin 10 mg QD |
| Lorcaserin 10 mg twice a day (BID)Also: APD356Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks. | Drug | Lorcaserin 10 mg BID |
| Matching PlaceboMatching placebo tablet each morning and evening for a duration of 52 weeks. | Drug | Matching Placebo |
Primary outcome
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52
Time frame: Baseline and Week 52
The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.
1 secondary outcome
Percent Change in Body Weight From Baseline to Week 52
Time frame: Baseline and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28345809Magkos F, Nikonova E, Fain R, Zhou S, Ma T, Shanahan W. Effect of lorcaserin on glycemic parameters in patients with type 2 diabetes mellitus. Obesity (Silver Spring). 2017 May;25(5):842-849. doi: 10.1002/oby.21798. Epub 2017 Mar 27.
- Derived from this study: PubMed 27888609Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26.
- Derived from this study: PubMed 27659698Handelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19.
- Derived from this study: PubMed 27389084Pi-Sunyer X, Shanahan W, Fain R, Ma T, Garvey WT. Impact of lorcaserin on glycemic control in overweight and obese patients with type 2 diabetes: analysis of week 52 responders and nonresponders. Postgrad Med. 2016 Aug;128(6):591-7. doi: 10.1080/00325481.2016.1208618. Epub 2016 Jul 18.
- Derived from this study: PubMed 27206567Nguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17.
- Derived from this study: PubMed 23661689Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9.
- Derived from this study: PubMed 22421927O'Neil PM, Smith SR, Weissman NJ, Fidler MC, Sanchez M, Zhang J, Raether B, Anderson CM, Shanahan WR. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity (Silver Spring). 2012 Jul;20(7):1426-36. doi: 10.1038/oby.2012.66. Epub 2012 Mar 16.
- Arena Pharmaceuticals, Inc. Home PageLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 once daily (QD) and Lorcaserin 10 mg twice a day (BID) in people with Obesity, run by Eisai Inc. at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 7 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52 (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00603291, which also lists 7 linked publications.
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 Oct 2019.