ObesityPhase 4NCT02229214
Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects
A Phase 4 study testing Qsymia in people with Obesity, run by VIVUS LLC at 1 site in United States.
Trial summary
The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of off-treatment recovery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Qsymia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Nov 2014
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 - 65 years of age, medically healthy with no clinically significant screening abnormalities
- BMI of ≥27 to ≤45 kg/m2
- No use of any medication (prescription, over the counter (OTC) or herbal preparations) with the exception of contraception for the entirety of the study
Who cannot join
- Allergy or hypersensitivity to radio contrast media, iodine or shellfish
- Plans to significantly alter their diet through fasting, very low caloric intake, elimination of certain foods (gluten, milk, meat, etc.) or similar
- Plans to undertake a significant change to physical exercise levels (i.e., initiate training for a marathon) during the study period
- Consumption of a high protein diet or protein/body building meal supplementation and/or replacement. The use of any product containing creatine is strictly prohibited
- History of glaucoma or increased intraocular pressure
- History of bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression, current depression of moderate or greater severity, presence or history of suicidal behavior or ideation with some intent to act on it
Show all 10Show fewer
- Cholelithiasis (gallstones) within the past 6 months
- History of nephrolithiasis (kidney stones)
- Evidence of any clinically significant renal, pulmonary, hepatic, psychiatric or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations or confound the interpretation of study results as determined by the investigator
- Current use of any tobacco products including cigarettes, cigars, pipes, and chewing tobacco, or nicotine replacement products (e.g., patch, gum, lozenge, etc.), or chronic use within the previous three months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of VI-0521 on the Glomerular Filtration Rate of Healthy Overweight or Obese Subjects
The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of off-treatment recovery.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single-site study in healthy overweight or obese male and female volunteers. Oral VI-0521 (combination of phentermine and topiramate [PHEN/TPM] extended-release capsule) will be administered daily as follows:
- Days 1-3: PHEN/TPM 3.75 mg /23 mg
- Days 4-6: PHEN/TPM 7.5 mg /46 mg
- Days 7-9: PHEN/TPM 11.25 mg /69 mg
- Days 10-28: PHEN/TPM 15 mg /92 mg
A single dose of Iohexol (a non-radioactive iodine-containing contrast agent) will be administered intravenously on three separate occasions.
The study will include a total of 50 healthy subjects (40 active and 10 placebo), all of whom will have overnight stays on 3 separate occasions.
Total study duration is approximately 10 weeks (2 weeks screening, 4 weeks study treatment, 4 weeks post treatment follow up).
- Conditions
- Obesity
- Being tested
- Qsymia, Placebo
- Keywords
- Renal function, Glomerular Filtration Rate, Kidney function, Qsymia, Iohexol, Serum Creatinine, Creatinine clearance, Renal Clearance, VI-0521, Healthy volunteers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QsymiaDrug
Also called VI-0521, Phentermine and Topiramate ER (Extended Release)
PlaceboDrug
Also called Sugar Pill
| Study group | Role | What they receive |
|---|---|---|
| VI-0521 (Qsymia) | Experimental | * Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg) Receives: Drug: Qsymia |
| Sugar pill | Placebo comparator | Days 1-28: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment
Method that uses iohexol clearance and body surface area to measure kidney function.
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR.
Measured: Baseline, end of treatment
Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment
Method that uses iohexol clearance and body surface area to measure kidney function.
Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR
Measured: Baseline, 28 days after end of treatment
Secondary outcomes (6)
Change in Serum Creatinine From Baseline to End of Treatment
Measured: Baseline, end of treatment
Change in Serum Creatinine From Baseline to 28 Days After End of Treatment
Measured: Baseline, 28 days after end of treatment
Change in Cystatin C From Baseline to End of Treatment
Measured: Baseline, end of treatment
Change in Cystatin C From Baseline to 28 Days After End of Treatment
Measured: Baseline, 28 days after end of treatment
Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment
Measured: Baseline, end of treatment
Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment
Measured: Baseline, 28 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Galloway, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229214
- Sponsor's protocol ID
- OB-404
- Status last verified
- Oct 2017
- First submitted
- 26 Aug 2014
- Last updated
- 7 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of VI-0521 on the Glomerular Filtration Rate of Healthy Overweight or Obese Subjects
- ClinicalTrials.gov ID
- NCT02229214
- Acronym / sponsor ID
- OB-404
- Conditions
- Obesity
- Keywords
- Renal function, Glomerular Filtration Rate, Kidney function, Qsymia, Iohexol, Serum Creatinine, Creatinine clearance, Renal Clearance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Posted 9 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of off-treatment recovery.
Detailed description
This is a randomized, double-blind, placebo-controlled, single-site study in healthy overweight or obese male and female volunteers. Oral VI-0521 (combination of phentermine and topiramate [PHEN/TPM] extended-release capsule) will be administered daily as follows:
- Days 1-3: PHEN/TPM 3.75 mg /23 mg
- Days 4-6: PHEN/TPM 7.5 mg /46 mg
- Days 7-9: PHEN/TPM 11.25 mg /69 mg
- Days 10-28: PHEN/TPM 15 mg /92 mg
A single dose of Iohexol (a non-radioactive iodine-containing contrast agent) will be administered intravenously on three separate occasions.
The study will include a total of 50 healthy subjects (40 active and 10 placebo), all of whom will have overnight stays on 3 separate occasions.
Total study duration is approximately 10 weeks (2 weeks screening, 4 weeks study treatment, 4 weeks post treatment follow up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VI-0521 (Qsymia) | Experimental | Drug: Qsymia* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg) * Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg) * Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg) * Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg) |
| Sugar pill | Placebo comparator | Drug: PlaceboDays 1-28: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female 18 - 65 years of age, medically healthy with no clinically significant screening abnormalities
- BMI of ≥27 to ≤45 kg/m2
- No use of any medication (prescription, over the counter (OTC) or herbal preparations) with the exception of contraception for the entirety of the study
Key exclusion criteria (10 listed)
- Allergy or hypersensitivity to radio contrast media, iodine or shellfish
- Plans to significantly alter their diet through fasting, very low caloric intake, elimination of certain foods (gluten, milk, meat, etc.) or similar
- Plans to undertake a significant change to physical exercise levels (i.e., initiate training for a marathon) during the study period
- Consumption of a high protein diet or protein/body building meal supplementation and/or replacement. The use of any product containing creatine is strictly prohibited
- History of glaucoma or increased intraocular pressure
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 |
|---|---|---|
| QsymiaAlso: VI-0521, Phentermine and Topiramate ER (Extended Release) | Drug | VI-0521 (Qsymia) |
| PlaceboAlso: Sugar Pill | Drug | Sugar pill |
Primary outcome
Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment
Time frame: Baseline, end of treatment
Method that uses iohexol clearance and body surface area to measure kidney function. Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR.
Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment
Time frame: Baseline, 28 days after end of treatment
Method that uses iohexol clearance and body surface area to measure kidney function. Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR
6 secondary outcomes
Change in Serum Creatinine From Baseline to End of Treatment
Time frame: Baseline, end of treatment
Change in Serum Creatinine From Baseline to 28 Days After End of Treatment
Time frame: Baseline, 28 days after end of treatment
Change in Cystatin C From Baseline to End of Treatment
Time frame: Baseline, end of treatment
Change in Cystatin C From Baseline to 28 Days After End of Treatment
Time frame: Baseline, 28 days after end of treatment
Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment
Time frame: Baseline, end of treatment
Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment
Time frame: Baseline, 28 days after end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- 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.
Chris Galloway, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Qsymia in people with Obesity, run by VIVUS LLC 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 10 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 7 Nov 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Feb 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?
Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment (time frame: Baseline, end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2017.