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NCT02301416 · ClinicalTrials.gov registry record · Phase 2

Qsymia as an Adjunct to Surgical Therapy in the Superobese

A Phase 2 study of Obesity and Weight Loss, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target
1
Study location

NCT02301416: Completed Phase 2 study of Obesity and Weight Loss, sponsored by Wake Forest University Health Sciences.

NCT02301416 is a Phase 2 study of Obesity and Weight Loss that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 25 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02301416, a Phase 2 study of Obesity and Weight Loss, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese individuals planning to undergo weight loss surgery. Individuals taking the medication before and after surgery will be compared to historical controls who had surgery without taking the medication.

Primary Outcome

Proportion of patients who do not meet the criteria to move forward with a second surgical procedure following an initial procedure plus the medication Qsymia. The criteria that suggest RYGB is indicated are: 1) BMI of 40 or greater or 2) BMI of 35-39.9 with poorly controlled co-morbidities.

Interventions

  • DRUG Phentermine/topiramate
  • OTHER low calorie diet

Study Locations (1)

North Carolina

  • Wake Forest Baptist Health - Winston-Salem

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2014-12
Est. Completion 2018-06-27
Phase Phase 2
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT02301416 record still lists

NCT02301416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower).

The record links to 4 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Phentermine/topiramate is the first listed.

NCT02301416 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT02301416 about?

NCT02301416 is a clinical study titled "Qsymia as an Adjunct to Surgical Therapy in the Superobese". This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese individuals planning to undergo weight loss surgery. Individuals taking the medication before and after surgery will be compared to historical controls who had surgery without taking the medication.

What is the current status of trial NCT02301416?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2014-12. Estimated completion is 2018-06-27.

What conditions does trial NCT02301416 study?

This clinical trial studies the following conditions: Obesity, Weight Loss, Metabolic Surgery, Bariatric Surgery Procedures.

What interventions are being tested in trial NCT02301416?

The interventions under investigation include: Phentermine/topiramate (DRUG), low calorie diet (OTHER).

Who is sponsoring clinical trial NCT02301416?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02301416 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02301416's enrollment target sits among peer trials

25 904th of 1053 higher than 146 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02301416, the US trial registry maintained by the National Library of Medicine. NCT02301416 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.