Trial · NCT04095104

Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

NCT04095104, Phase 2, Completed, University of Colorado, Denver; results first posted 2025-05-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds. Trials, record NCT04095104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04095104

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds
NCT number: NCT04095104
Status: Completed
Phases: Phase 2
Enrollment: 13 participants, actual
Lead sponsor: University of Colorado, Denver
Conditions: Obesity, Morbid, Bariatric Surgery, Adolescent, Young Adult, Drug Therapy
Interventions: Phentermine, Immediate Release Topiramate, Placebo for Phentermine, Placebo for Immediate Release Topiramate
First posted: 2019-09-19
Last updated: 2025-05-23
Results first posted: 2025-05-23

Source ClinicalTrials.gov

Registered outcomes28

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Enrollment Rate	6 months	(Number enrolled divided by number eligible) x 100
Primary	Dropout Rate	24 months	Number who do not complete the study divided by number enrolled
Primary	Number of Participants Adherent to Study Drugs	12 weeks	Presence of amphetamine in the urine at any study visit
Primary	Frequency of Adverse Events	24 months	Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.
Secondary	Percent BMI Change	Baseline and 12 weeks	(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100
Secondary	Percent Weight Change	Baseline and 12 weeks	(Baseline weight - weight at 12 weeks)/Baseline weight x 100
Secondary	Change in BMI Percent of the 95th%Ile	Baseline and 12 weeks	(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)
Secondary	Change in Heart Rate	Baseline and 12 weeks	(Heart rate at baseline - Heart rate at 12 weeks)
Secondary	Change in Systolic Blood Pressure	Baseline and 12 weeks	Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks
Secondary	Change in Diastolic Blood Pressure	Baseline and 12 weeks	Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks

1 to 10 of 28Source ClinicalTrials.gov

See all 28 registered outcomes

Outcomes28

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Enrollment Rate	6 months		percentage of participants	NUMBER
PRIMARY	Dropout Rate	24 months		percentage who withdrew among enrolled	NUMBER
PRIMARY	Number of Participants Adherent to Study Drugs	12 weeks	The one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Frequency of Adverse Events	24 months	The one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.	unique adverse events per participant	MEAN
SECONDARY	Percent BMI Change	Baseline and 12 weeks		percent change	MEAN
SECONDARY	Percent Weight Change	Baseline and 12 weeks		percent change	MEAN
SECONDARY	Change in BMI Percent of the 95th%Ile	Baseline and 12 weeks	For 1 member of the active group and 2 members of the placebo group, it was not appropriate to calculate a % above the 95th%ile either because BMI was \<95th%ile or they were \>19 completed years at the time point.	percentile change	MEAN
SECONDARY	Change in Heart Rate	Baseline and 12 weeks		beats per minute	MEAN
SECONDARY	Change in Systolic Blood Pressure	Baseline and 12 weeks		mmHg	MEAN
SECONDARY	Change in Diastolic Blood Pressure	Baseline and 12 weeks		mmHg	MEAN

1 to 10 of 28Source ClinicalTrials.gov

See all 28 outcomes

Results by group55

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Enrollment Rate	All Eligible Participants Before Randomization	19		percentage of participants
Dropout Rate	Phentermine & Topiramate	0		percentage who withdrew among enrolled
Dropout Rate	Placebo	7.7		percentage who withdrew among enrolled
Number of Participants Adherent to Study Drugs	Phentermine & Topiramate	5		Participants
Number of Participants Adherent to Study Drugs	Placebo	0		Participants
Frequency of Adverse Events	Phentermine & Topiramate	16	Full Range 10 to 27	unique adverse events per participant
Frequency of Adverse Events	Placebo	8	Full Range 1 to 16	unique adverse events per participant
Percent BMI Change	Phentermine & Topiramate	-3.61	Full Range -13 to 2.86	percent change
Percent BMI Change	Placebo	1.89	Full Range -0.06 to 4.62	percent change
Percent Weight Change	Phentermine & Topiramate	-4.72	Full Range -12.14 to 2.61	percent change

1 to 10 of 55Source ClinicalTrials.gov

See all 55 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phentermine & Topiramate	6
Overall Study	STARTED	Placebo	7
Overall Study	COMPLETED	Phentermine & Topiramate	6
Overall Study	COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Phentermine & Topiramate	0
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events94

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Restlessness	General disorders	Phentermine & Topiramate	6	6
other	Restlessness	General disorders	Placebo	2	6
other	Depressed mood	Psychiatric disorders	Phentermine & Topiramate	4	6
other	Depressed mood	Psychiatric disorders	Placebo	3	6
other	Difficulty with sleep	General disorders	Phentermine & Topiramate	4	6
other	Difficulty with sleep	General disorders	Placebo	3	6
other	Fatigue	General disorders	Phentermine & Topiramate	5	6
other	Fatigue	General disorders	Placebo	2	6
other	Irritability	Psychiatric disorders	Phentermine & Topiramate	6	6
other	Irritability	Psychiatric disorders	Placebo	1	6

1 to 10 of 94Source ClinicalTrials.gov

See all 94 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phentermine & Topiramate	0	6
Total, all-cause mortality	Placebo	0	6
Total, other adverse events	Phentermine & Topiramate	6	6
Total, other adverse events	Placebo	6	6
Total, serious adverse events	Phentermine & Topiramate	1	6
Total, serious adverse events	Placebo	0	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30DK048520	Colorado Nutrition Obesity Research Center	MACLEAN, PAUL S.	UNIVERSITY OF COLORADO DENVER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	1995 to 2025

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Phentermine & Topiramate vs Placebo: Number of Participants Adherent to Study Drugs	Trial comparisons
Phentermine & Topiramate vs Placebo: deaths from any cause	Trial comparisons
Phentermine & Topiramate vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04095104

GET https://conductscience.org/api/trials/v1/NCT04095104/registered?page=2

API reference For AI assistants