Trial Outcomes & Findings for Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker (NCT NCT04408586)

Results Overview

Change in weight calculated in kilograms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

baseline, 3 months

Results posted on

2023-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	Phentermine - Topiramate Extended Release Group Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Overall Study STARTED	42	38
Overall Study COMPLETED	42	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phentermine - Topiramate Extended Release Group n=42 Participants Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group n=38 Participants Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Total n=80 Participants Total of all reporting groups
Age, Continuous	43.4 years STANDARD_DEVIATION 10.9 • n=5 Participants	40.8 years STANDARD_DEVIATION 10.2 • n=7 Participants	42 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	32 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	37 Participants n=7 Participants	79 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	38 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 3 months

Change in weight calculated in kilograms.

Outcome measures

Outcome measures
Measure	Phentermine - Topiramate Extended Release Group n=42 Participants Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group n=38 Participants Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Body Weight Change	-10.80 kilograms Interval -13.72 to -7.92	-4.04 kilograms Interval -7.05 to -1.04

SECONDARY outcome

Timeframe: baseline, 12 months

Change in weight calculated in kilograms.

Outcome measures

Outcome measures
Measure	Phentermine - Topiramate Extended Release Group n=42 Participants Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group n=38 Participants Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Body Weight Change	-15.32 kilograms Interval -18.65 to -12.0	-5.85 kilograms Interval -9.4 to -2.3

SECONDARY outcome

Timeframe: baseline,12 months

The change in the number of steps per day

Outcome measures

Outcome measures
Measure	Phentermine - Topiramate Extended Release Group n=42 Participants Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group n=38 Participants Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Change in Step Count	1214 steps per day Interval -192.0 to 2620.0	2316 steps per day Interval 807.0 to 3824.0

SECONDARY outcome

Timeframe: baseline, 12 months

The change in calories burned per day

Outcome measures

Outcome measures
Measure	Phentermine - Topiramate Extended Release Group n=42 Participants Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group n=38 Participants Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Change in Calories	-193 kcal per day Interval -356.0 to -30.0	60 kcal per day Interval -127.0 to 247.0

SECONDARY outcome

Timeframe: 12 months

The number of exercise sessions per week

Outcome measures

Outcome measures
Measure	Phentermine - Topiramate Extended Release Group n=42 Participants Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group n=38 Participants Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Exercise Sessions	2.3 sessions per week Standard Deviation 1	2.1 sessions per week Standard Deviation 1

SECONDARY outcome

Timeframe: 12 months

The amount of time in minutes the tracker was used per week

Outcome measures

Outcome measures
Measure	Phentermine - Topiramate Extended Release Group n=42 Participants Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group n=38 Participants Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Tracker Usage	90 minutes/week Standard Deviation 15	94 minutes/week Standard Deviation 12

SECONDARY outcome

Timeframe: baseline, 12 months

Quality of life SF12 physical score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome

Outcome measures

Outcome measures
Measure	Phentermine - Topiramate Extended Release Group n=42 Participants Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group n=38 Participants Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Change in SF-12 Physical Score (Health-related Quality Quality of Life)	1.99 score on a scale Interval -0.34 to 4.32	0.57 score on a scale Interval -1.76 to 2.9

SECONDARY outcome

Timeframe: baseline, 12 months

Quality of life SF12 mental score. The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.

Outcome measures

Outcome measures
Measure	Phentermine - Topiramate Extended Release Group n=42 Participants Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group n=38 Participants Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Change in SF-12 Mental Score (Health-related Quality Quality of Life)	0.42 score on a scale Interval -1.66 to 2.5	-1.48 score on a scale Interval -3.56 to 0.6

Adverse Events

Phentermine - Topiramate Extended Release Group

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Phentermine - Topiramate Extended Release Group n=42 participants at risk Phentermine-Topiramate Extended Release: Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.	Placebo Group n=38 participants at risk Placebo: Placebo looks exactly like the study drug, but it contained no active ingredient Online support system: VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices that was used as part of this study. It also allowed subjects to document study medication compliance and allowed the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Nervous system disorders Paresthesia	14.3% 6/42 • Number of events 6 • Adverse Events were collected from baseline to end of study, approximately 12 months for each subject	2.6% 1/38 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 12 months for each subject
Gastrointestinal disorders Dry mouth	7.1% 3/42 • Number of events 3 • Adverse Events were collected from baseline to end of study, approximately 12 months for each subject	5.3% 2/38 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 12 months for each subject
Nervous system disorders Dysgeusia	7.1% 3/42 • Number of events 3 • Adverse Events were collected from baseline to end of study, approximately 12 months for each subject	0.00% 0/38 • Adverse Events were collected from baseline to end of study, approximately 12 months for each subject
Psychiatric disorders Insomnia	7.1% 3/42 • Number of events 3 • Adverse Events were collected from baseline to end of study, approximately 12 months for each subject	0.00% 0/38 • Adverse Events were collected from baseline to end of study, approximately 12 months for each subject
Nervous system disorders Headache	4.8% 2/42 • Number of events 2 • Adverse Events were collected from baseline to end of study, approximately 12 months for each subject	0.00% 0/38 • Adverse Events were collected from baseline to end of study, approximately 12 months for each subject

Additional Information

Andres J. Acosta, M.D., Ph.D.

Mayo Clinic

Phone: 507-266-6931

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place