ObesityPhase 2REVIVENCT01351753
Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity
A Phase 2 study testing Metformin, Orlistat and Topiramate in people with Obesity and Metabolic Syndrome X, run by University of Iowa at 1 site in United States.
Trial summary
Obesity is common (>30% of US adults), contributes to substantial morbidity and mortality, but is difficult to treat. Partly this is due to the transient, arduous and modest nature of lifestyle interventions. Partly it is due to the limited efficacy and safety problems of existing pharmacotherapy. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Obesity, Metabolic Syndrome X
- What is being tested?
- Metformin, Orlistat and Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 9 Jan 2014
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 75 years
- Male or postmenopausal female
- BMI ≥ 30 kg/m2
- One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome)
Who cannot join
- Congestive heart failure
- Renal impairment
- History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion)
- Type I diabetes mellitus
- Weight loss > 10% in the past 6 months
- Recurrent nephrolithiasis
Show all 18Show fewer
- Current treatment for seizure disorder
- Hepatic cirrhosis
- Current use of study medications
- Current use of oral estrogen
- History of smoking cessation in the past three months
- Current cholestasis or malabsorption syndrome
- Planned use of any herbal or over-the-counter supplements for weight loss
- History of allergic reactions to metformin, topiramate, orlistat or any of ingredients
- Medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours
- Participation in another clinical drug study within four weeks prior to this investigation.
- Participation in any other weight loss or rigorous exercise program.
- Any disease or condition that in the opinion of the investigator may interfere with completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52241
About this study
Official title: Does Reversal of Visceral Obesity by Drug Therapy Improve Vascular Function?
Obesity is common (>30% of US adults), contributes to substantial morbidity and mortality, but is difficult to treat. Partly this is due to the transient, arduous and modest nature of lifestyle interventions. Partly it is due to the limited efficacy and safety problems of existing pharmacotherapy. Only one drug, orlistat, is approved for long-term use in obesity; but its effects on weight are relatively small. There are drugs that have been approved for other diseases but which also reduce weight. One promising approach to treating obesity is combination therapy with orlistat and one or more of these other agents. The investigators propose an innovative approach to developing new therapies for obesity coupling the use of combination therapy with rigorous assessment of cardiovascular safety. Vascular function is a quantitative surrogate clinical endpoint that has been strongly and independently linked to future cardiovascular events.
Our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular function in obese human subjects. The co-primary endpoints will be weight and vascular function.
- Conditions
- Obesity, Metabolic Syndrome X
- Being tested
- Metformin, Orlistat, Topiramate, Placebo
- Keywords
- Obesity, Metabolic Syndrome X, Hypertension, Dyslipidemia, Impaired glucose tolerance
- Medical subject headings
- Obesity, Metabolic Syndrome, Hypertension, Dyslipidemias, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
OrlistatDrug
TopiramateDrug
PlaceboDrug
Placebo pills and capsules for metformin, orlistat and topiramate
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Not described Receives: Drug: Metformin |
| Metformin + Orlistat | Experimental | Not described Receives: Drug: Metformin; Drug: Orlistat |
| Metformin + Topiramate | Experimental | Not described Receives: Drug: Metformin; Drug: Topiramate |
| Topiramate | Experimental | Not described Receives: Drug: Topiramate |
| Metformin + Topiramate + Orlistat | Experimental | Not described Receives: Drug: Metformin; Drug: Orlistat; Drug: Topiramate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (Percent Change From Baseline)
Weight obtained in the fasting state on a gowned subject.
Measured: Baseline and 6 months
Secondary outcomes (3)
Office Systolic Blood Pressure (mmHg Change From Baseline)
Automated sphygmomanometry while sitting
Measured: Baseline and 6 months
Centimeter Change in Waist Circumference
Waist circumference for central adiposity
Measured: Baseline and 6 months
Carotid-femoral Pulse Wave Velocity (PWV)(Change After 6 Months From Baseline)
Change in carotid-femoral pulse wave velocity in meters/second (Sphygmocor).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMar 2011
- Primary completion9 Jan 2014
- Study completion9 Jan 2014
Why it stopped: Lack of funding
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 (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary L. Pierce, PhD, University of Iowa
- Investigators
- Gary L Pierce, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351753
- Sponsor's protocol ID
- 201012738
- Acronym
- REVIVE
- Status last verified
- Feb 2026
- First submitted
- 4 May 2011
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kokkorakis M, Chakhtoura M, Rhayem C, Al Rifai J, Ghezzawi M, Valenzuela-Vallejo L, Mantzoros CS. Emerging pharmacotherapies for obesity: A systematic review. Pharmacol Rev. 2025 Jan;77(1):100002. doi: 10.1124/pharmrev.123.001045. Epub 2024 Nov 22.
PubMed 39952695
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Reversal of Visceral Obesity by Drug Therapy Improve Vascular Function?
- ClinicalTrials.gov ID
- NCT01351753
- Acronym / sponsor ID
- REVIVE / 201012738
- Conditions
- Obesity, Metabolic Syndrome X
- Keywords
- Obesity, Metabolic Syndrome X, Hypertension, Dyslipidemia, Impaired glucose tolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- 9 Jan 2014 (actual)
- Study completion
- 9 Jan 2014 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Posted 9 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is common (>30% of US adults), contributes to substantial morbidity and mortality, but is difficult to treat. Partly this is due to the transient, arduous and modest nature of lifestyle interventions. Partly it is due to the limited efficacy and safety problems of existing pharmacotherapy. Only one drug, orlistat, is approved for long-term use in obesity; but its effects on weight are relatively small. There are drugs that have been approved for other diseases but which also reduce weight. One promising approach to treating obesity is combination therapy with orlistat and one or more of these other agents. The investigators propose an innovative approach to developing new therapies for obesity coupling the use of combination therapy with rigorous assessment of cardiovascular safety. Vascular function is a quantitative surrogate clinical endpoint that has been strongly and independently linked to future cardiovascular events.
Our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular function in obese human subjects. The co-primary endpoints will be weight and vascular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin |
| Metformin + Orlistat | Experimental | Drug: Metformin, Drug: Orlistat |
| Metformin + Topiramate | Experimental | Drug: Metformin, Drug: Topiramate |
| Topiramate | Experimental | Drug: Topiramate |
| Metformin + Topiramate + Orlistat | Experimental | Drug: Metformin, Drug: Orlistat, Drug: Topiramate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40 to 75 years
- Male or postmenopausal female
- BMI ≥ 30 kg/m2
- One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome)
Key exclusion criteria (18 listed)
- Congestive heart failure
- Renal impairment
- History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion)
- Type I diabetes mellitus
- Weight loss > 10% in the past 6 months
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 |
|---|---|---|
| Metformin | Drug | Metformin, Metformin + Orlistat, Metformin + Topiramate, Metformin + Topiramate + Orlistat |
| Orlistat | Drug | Metformin + Orlistat, Metformin + Topiramate + Orlistat |
| Topiramate | Drug | Metformin + Topiramate, Metformin + Topiramate + Orlistat, Topiramate |
| PlaceboPlacebo pills and capsules for metformin, orlistat and topiramate | Drug | Placebo |
Primary outcome
Weight (Percent Change From Baseline)
Time frame: Baseline and 6 months
Weight obtained in the fasting state on a gowned subject.
3 secondary outcomes
Office Systolic Blood Pressure (mmHg Change From Baseline)
Time frame: Baseline and 6 months
Centimeter Change in Waist Circumference
Time frame: Baseline and 6 months
Carotid-femoral Pulse Wave Velocity (PWV)(Change After 6 Months From Baseline)
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39952695Kokkorakis M, Chakhtoura M, Rhayem C, Al Rifai J, Ghezzawi M, Valenzuela-Vallejo L, Mantzoros CS. Emerging pharmacotherapies for obesity: A systematic review. Pharmacol Rev. 2025 Jan;77(1):100002. doi: 10.1124/pharmrev.123.001045. Epub 2024 Nov 22.
- Recruitment websiteLink 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.
Gary L Pierce, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin, Orlistat and Topiramate in people with Obesity and Metabolic Syndrome X, run by University of Iowa 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 4 inclusion and 18 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: stopped early, as of the sponsor's last update on 12 Mar 2026. 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 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 9 Jun 2021). 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?
Weight (Percent Change From Baseline) (time frame: Baseline and 6 months). 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 NCT01351753, which also lists 1 linked publication.
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 12 Mar 2026.