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Obesity drug cocktail tested for heart benefits – study halted early

NCT ID NCT01351753

Disease control Sponsor: University of Iowa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether using a combination of weight-loss medications could help people with obesity lose weight and improve the health of their blood vessels. It involved 128 adults aged 40-75 who were obese and had at least one heart risk factor. The study was stopped early, so results are limited, but the goal was to find a safer, more effective drug approach to manage obesity and reduce heart disease risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

128 people

The number who actually took part.

Started

Mar 2011

Finished

Jan 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

Dyslipidemias glucose intolerance hypertensive disorder metabolic syndrome X Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic syndrome X Obesity

Contacts and locations

Locations

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52241, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.