Trial Outcomes & Findings for Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity (NCT NCT04881799)
NCT ID: NCT04881799
Last Updated: 2026-05-22
Results Overview
The percent change in body mass index (BMI) from Baseline to Month 6 will be calculated. BMI is defined as a person's weight in kilograms divided by the square of height in meters. The Phase 1 (double-blind) portion of the study was six months and data were collected at the end of the 6 month double-blind phase.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
EARLY_PHASE1
Target enrollment
13 participants
Primary outcome timeframe
6 Months
Results posted on
2026-05-22
Participant Flow
Participants were recruited via care provider, IRB approved flyer and IRB approved recruitment letters.
Participant milestones
| Measure |
Placebo -> Qsymia
Participants in this arm started the study using a placebo pill that they took in the morning.
At the open label extension they were moved onto Qsymia and titrated the dose in the same manner as the Qsymia -\> Qsymia group
|
Qsymia -> Qsymia
Participants in this group started the double-blind portion of the study by taking Qsymia orally in the morning. Participants started with a dose of 3.75 mg/23 mg for 14 days, titrated to 7.5 mg/46 mg for 14 days, titrated to 11.25 mg/69 mg for 14 days and then titrated to the final dose of 15 mg/92 mg and stayed there for the duration of the study, including the open label portion of the project.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo -> Qsymia
Participants in this arm started the study using a placebo pill that they took in the morning.
At the open label extension they were moved onto Qsymia and titrated the dose in the same manner as the Qsymia -\> Qsymia group
|
Qsymia -> Qsymia
Participants in this group started the double-blind portion of the study by taking Qsymia orally in the morning. Participants started with a dose of 3.75 mg/23 mg for 14 days, titrated to 7.5 mg/46 mg for 14 days, titrated to 11.25 mg/69 mg for 14 days and then titrated to the final dose of 15 mg/92 mg and stayed there for the duration of the study, including the open label portion of the project.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity
Baseline characteristics by cohort
| Measure |
Placebo -> Qsymia
n=7 Participants
Participants in this phase of the study will be randomized 1:1 to receive placebo during the double blind portion of the study and then to receive Qsymia for the open label portion of the study.
Placebo: Daily pill taken in the morning. Qsymia: Qsymia will be taken via pill in the morning. Doses will be titrated upwards as follows: 3.75 mg/23 mg for 14 days, titrated to 7.5 mg/46 mg for 14 days, titrated to 11.25 mg/69 mg for 14 days and then to 15 mg/92 mg where they will remain for the rest of the study.
|
Qsymia -> Qsymia
n=6 Participants
Participants will receive Qsymia during the double-blind and the open label portion of the study.
Qsymia will be taken via pill in the morning. Doses will be titrated upwards as follows: 3.75 mg/23 mg for 14 days, titrated to 7.5 mg/46 mg for 14 days, titrated to 11.25 mg/69 mg for 14 days and then to 15 mg/92 mg where they will remain for the rest of the study.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=2 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=2 Participants
|
6 participants
n=4 Participants
|
24 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsThe percent change in body mass index (BMI) from Baseline to Month 6 will be calculated. BMI is defined as a person's weight in kilograms divided by the square of height in meters. The Phase 1 (double-blind) portion of the study was six months and data were collected at the end of the 6 month double-blind phase.
Outcome measures
| Measure |
Placebo -> Qsymia
n=7 Participants
Participants in this phase of the study will be randomized to receive placebo for the double-blind portion of the study and then will receive Qsymia for the open-label portion of the study.
Placebo: Daily pill
Qsymia: Qsymia will be taken via pill in the morning. Doses will be titrated upwards as follows: 3.75 mg/23 mg for 14 days, titrated to 7.5 mg/46 mg for 14 days, titrated to 11.25 mg/69 mg for 14 days and then to 15 mg/92 mg where they will remain for the rest of the study.
|
Qsymia -> Qsymia
n=6 Participants
Participants in this portion of the study will be randomized to receive Qsymia for both the double-blind and the open-label portions of the study.
Qsymia will be taken via pill in the morning. Doses will be titrated upwards as follows: 3.75 mg/23 mg for 14 days, titrated to 7.5 mg/46 mg for 14 days, titrated to 11.25 mg/69 mg for 14 days and then to 15 mg/92 mg where they will remain for the rest of the study.
|
|---|---|---|
|
Change in Body Mass Index
|
0.3 Percent change in BMI
Standard Deviation 3.0
|
-6.4 Percent change in BMI
Standard Deviation 3.8
|
Adverse Events
Phase 1: Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 1: Qsymia
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2: Qsymia
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1: Placebo
n=7 participants at risk
Participants in this portion of the study were randomized 1:1 to take a placebo during the double-blind portion of the study.
Placebo: Daily pill taken in the morning. Qsymia: Qsymia will be taken via pill in the morning. Doses will be titrated upwards as follows: 3.75 mg/23 mg for 14 days, titrated to 7.5 mg/46 mg for 14 days, titrated to 11.25 mg/69 mg for 14 days and then to 15 mg/92 mg where they will remain for the rest of the study.
|
Phase 1: Qsymia
n=6 participants at risk
Participants in this portion of the study were randomized 1:1 to take Qsymia during the double-blind and open-label portions of the study.
Qsymia will be taken via pill in the morning. Doses will be titrated upwards as follows: 3.75 mg/23 mg for 14 days, titrated to 7.5 mg/46 mg for 14 days, titrated to 11.25 mg/69 mg for 14 days and then to 15 mg/92 mg where they will remain for the rest of the study.
|
Phase 2: Qsymia
n=11 participants at risk
All participants in this phase of the study received open label phentermine/topiramate (Qsymia). A maximum dose of 15 mg/92 mg orally once daily in the morning. The dose was titrated to this level.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fractured Finger
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
16.7%
1/6 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/11 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Nervous system disorders
Generalized Pain
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
16.7%
1/6 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/11 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Infections and infestations
Streptococcal Pharyngitis
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Eye disorders
Epiphora
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 2 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Psychiatric disorders
Insomnia
|
57.1%
4/7 • Number of events 8 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
33.3%
2/6 • Number of events 4 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
45.5%
5/11 • Number of events 16 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Nervous system disorders
Sleepiness
|
28.6%
2/7 • Number of events 7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
50.0%
3/6 • Number of events 6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
27.3%
3/11 • Number of events 9 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Nervous system disorders
Concentration Impaired
|
28.6%
2/7 • Number of events 3 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
66.7%
4/6 • Number of events 9 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
18.2%
2/11 • Number of events 15 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Nervous system disorders
Memory Impairment
|
14.3%
1/7 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
16.7%
1/6 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Nervous system disorders
Headaches
|
28.6%
2/7 • Number of events 6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
66.7%
4/6 • Number of events 9 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
27.3%
3/11 • Number of events 12 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
33.3%
2/6 • Number of events 3 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
16.7%
1/6 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
27.3%
3/11 • Number of events 3 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Vascular disorders
Edema
|
14.3%
1/7 • Number of events 4 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
28.6%
2/7 • Number of events 2 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
33.3%
2/6 • Number of events 4 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
27.3%
3/11 • Number of events 7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 5 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 5 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Ear and labyrinth disorders
Ear Infection
|
14.3%
1/7 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/11 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Nervous system disorders
Paresthesia
|
14.3%
1/7 • Number of events 7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
66.7%
4/6 • Number of events 5 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
45.5%
5/11 • Number of events 10 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Number of events 5 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 3 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • Number of events 5 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Number of events 4 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
33.3%
2/6 • Number of events 2 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 2 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Gastrointestinal disorders
Dry Mouth
|
28.6%
2/7 • Number of events 2 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
33.3%
2/6 • Number of events 5 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 3 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Psychiatric disorders
Agitation
|
14.3%
1/7 • Number of events 5 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
16.7%
1/6 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
0.00%
0/6 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
16.7%
1/6 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
9.1%
1/11 • Number of events 1 • AEs collected from Baseline to Week 52
FDA definition of SAE was utilized
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place