ObesityPhase 2NCT02243202

Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants

A Phase 2 study testing Canagliflozin and Phentermine in people with Obesity, run by Janssen Research & Development, LLC at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obesity
What is being tested?: Canagliflozin and Phentermine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 335 participants
Where: 17 sitesUnited States
Study dates: Sep 2014to Jun 2015
Phase: Phase 2
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

Must have BMI >=30 kg/m2 and <50 kg/m2 at screening or BMI >=27 kg/m2 and <50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia
Must have stable weight, ie, change of < =5% in the 3 months before screening
Must agree to utilize a highly effective method of birth control

Who cannot join

An established diagnosis of diabetes mellitus
Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)
Has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria
Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
Has an Glycated hemoglobin (HBA1c) greater than or equal (>=) to 65 percent
An average of 3 seated blood pressure (BP) readings of systolic BP >= 160 mm Hg and/or Diastolic BP >= 100 millimeters of mercury at screening

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Study site
Dallas, Texas
Study site
Evansville, Indiana
Study site
Jacksonville, Florida
Study site
Lexington, Kentucky
Study site
Louisville, Kentucky
Study site
Manlius, New York
Study site
Meridian, Idaho
Study site
Milford, Massachusetts
Study site
Mt. Pleasant, South Carolina
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
Norfolk, Virginia
Study site
Odessa, Texas
Study site
Phoenix, Arizona
Study site
Walnut Creek, California
Study site
Warwick, Rhode Island
Study site
Wauwatosa, Wisconsin

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese Subjects

The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.

Read the detailed description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants. The study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).

Conditions: Obesity
Being tested: Canagliflozin, Phentermine, Matching Placebo to Canagliflozin, Matching Placebo to Phentermine
Keywords: Obesity, Overweight, Canagliflozin, Phentermine, INVOKANA®
Medical subject headings: Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CanagliflozinDrug
Also called INVOKANA
300 mg capsule, taken once daily, orally for 26 weeks.
PhentermineDrug
15 mg capsule, taken once daily, orally for 26 weeks.
Matching Placebo to CanagliflozinDrug
Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
Matching Placebo to PhentermineDrug
Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.

Study groups in NCT02243202
Study group	Role	What they receive
Canagliflozin + Phentermine	Experimental	300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks. Receives: Drug: Canagliflozin; Drug: Phentermine
Canagliflozin + Placebo (Phentermine)	Experimental	300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks. Receives: Drug: Canagliflozin; Drug: Matching Placebo to Phentermine
Phentermine + Placebo (Canagliflozin)	Experimental	15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks. Receives: Drug: Phentermine; Drug: Matching Placebo to Canagliflozin
Placebo	Placebo comparator	Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks. Receives: Drug: Matching Placebo to Canagliflozin; Drug: Matching Placebo to Phentermine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Body Weight at Week 26
The percent change from baseline in body weight at Week 26 was analysed.
Measured: Week 26

Secondary outcomes (3)

Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
Percentage of participants with weight loss >= 5 percent were analysed at week 26.
Measured: Week 26
Change From Baseline in Systolic Blood Pressure at Week 26
Change from baseline in systolic blood pressure was analysed at week 26.
Measured: Week 26
Absolute Change From Baseline in Body Weight at Week 26
Absolute change from baseline in body weight was analysed at week 26.
Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Jun 2015

First posted17 Sep 2014 (estimated)
Study startSep 2014
Primary completionJun 2015
Study completionJun 2015

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.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 335 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02243202
Sponsor's protocol ID: CR103086
Other IDs: 28431754OBE2002
Status last verified: Aug 2016
First submitted: 16 Sep 2014
Last updated: 6 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese Subjects
ClinicalTrials.gov ID: NCT02243202
Acronym / sponsor ID: CR103086
Conditions: Obesity
Keywords: Obesity, Overweight, Canagliflozin, Phentermine, INVOKANA®
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 335 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 17 Sep 2014 (estimated)
Results: Posted 6 Oct 2016

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 compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Canagliflozin + Phentermine	Experimental	Drug: Canagliflozin, Drug: Phentermine300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
Canagliflozin + Placebo (Phentermine)	Experimental	Drug: Canagliflozin, Drug: Matching Placebo to Phentermine300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
Phentermine + Placebo (Canagliflozin)	Experimental	Drug: Phentermine, Drug: Matching Placebo to Canagliflozin15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
Placebo	Placebo comparator	Drug: Matching Placebo to Canagliflozin, Drug: Matching Placebo to PhentermineMatching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Must have BMI >=30 kg/m2 and <50 kg/m2 at screening or BMI >=27 kg/m2 and <50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia
Must have stable weight, ie, change of < =5% in the 3 months before screening
Must agree to utilize a highly effective method of birth control

Key exclusion criteria (6 listed)

An established diagnosis of diabetes mellitus
Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)
Has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria
Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
Has an Glycated hemoglobin (HBA1c) greater than or equal (>=) to 65 percent

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
CanagliflozinAlso: INVOKANA300 mg capsule, taken once daily, orally for 26 weeks.	Drug	Canagliflozin + Phentermine, Canagliflozin + Placebo (Phentermine)
Phentermine15 mg capsule, taken once daily, orally for 26 weeks.	Drug	Canagliflozin + Phentermine, Phentermine + Placebo (Canagliflozin)
Matching Placebo to CanagliflozinPlacebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.	Drug	Phentermine + Placebo (Canagliflozin), Placebo
Matching Placebo to PhenterminePlacebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.	Drug	Canagliflozin + Placebo (Phentermine), Placebo

Primary outcome

Percent Change From Baseline in Body Weight at Week 26
Time frame: Week 26
The percent change from baseline in body weight at Week 26 was analysed.

3 secondary outcomes

Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
Time frame: Week 26
Change From Baseline in Systolic Blood Pressure at Week 26
Time frame: Week 26
Absolute Change From Baseline in Body Weight at Week 26
Time frame: Week 26

Results and safety

Results posted to the registry on 6 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	82	57
Phentermine 15 mg	85	60
Canagliflozin 300 mg	84	53
Canagliflozin 300 mg/Phentermine 15 mg	84	61

Primary outcome: Percent Change From Baseline in Body Weight at Week 26

Time frame: Week 26. Least squares mean (Standard Error). Unit: Percent Change

Measure	Placebo n = 76	Phentermine 15 mg n = 76	Canagliflozin 300 mg n = 78	Canagliflozin 300 mg/Phentermine 15 mg n = 77
Value	-0.6 (0.6)	-4.1 (0.6)	-1.9 (0.6)	-7.5 (0.6)

Placebo vs Phentermine 15 mg: Least Square Mean Difference: -3.5 (95% CI -5.3 to -1.8), p <0.001, Mixed Model for Repeated Measures
Placebo vs Canagliflozin 300 mg: Least Square Mean Difference: -1.3 (95% CI -3.1 to 0.4), p = 0.142, Mixed Model for Repeated Measures
Placebo vs Canagliflozin 300 mg/Phentermine 15 mg: Least Square Mean Difference: -6.9 (95% CI -8.6 to -5.2), p <0.001, Mixed Model for Repeated Measures

Population analysed: The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 33 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 82 (0%)	41 of 82 (50%)	Not reported
Phentermine 15 mg	0 of 85 (0%)	37 of 85 (43.5%)	Not reported
Canagliflozin 300 mg	0 of 84 (0%)	42 of 84 (50%)	Not reported
Canagliflozin 300 mg/Phentermine 15 mg	1 of 83 (1.2%)	42 of 83 (50.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Canagliflozin and Phentermine in people with Obesity, run by Janssen Research & Development, LLC at 17 sites 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 6 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 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Oct 2016). 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?

Percent Change From Baseline in Body Weight at Week 26 (time frame: Week 26). 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 NCT02243202.

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 6 Oct 2016.