CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Phentermine-Topiramate Extended Release +2 moredrug
Likely dose
Phentermine-Topiramate Extended Release 23 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04408586
NCT04408586Phase 4Completed
CompareCT.gov

Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker.

Mayo Clinic·interventional·Posted May 29, 2020·Updated Jun 22, 2023

In Brief

A Phase 4 clinical trial evaluating Phentermine-Topiramate Extended Release, Placebo, and 1 other intervention for Obesity. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Researchers are assessing the effects of weight loss medication vs a placebo among participants provided with a wearable activity tracker, digital wellness devices and lifestyle recommendations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMay 29, 2020
Enrollment StartJun 3, 2020
Primary CompletionJun 13, 2022
Study CompletionOct 11, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.1 years ago

Interventions

Phentermine-Topiramate Extended Releasedrug

Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily

Placebodrug

Placebo looks exactly like the study drug, but it contains no active ingredient

Online support systemother

VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.