Phentermine's Impact on Treatment in Teens

ConditionChildhood Obesity

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age12-17

SponsorRussell McCulloh, MD

About this trial

PhITT is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of phentermine (16 mg daily) in adolescents aged 12 to \<18 years with obesity. Conducted across approximately 10 sites within the IDeA States Pediatric Clinical Trials Network (ISPCTN), the study aims to enroll up to 240 participants and then randomize up to 198 who meet eligibility criteria, randomized in a 2:1 ratio to phentermine or placebo over a 52-week treatment period, followed by a 2-week withdrawal assessment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 12 years and < 18 years at time of consent;

Tanner Staging ≥ 2 at the time of screening;

Obesity (BMI ≥ 95th age- and sex-specific CDC percentile or BMI ≥ 30 kg/m2);

Biological females must agree to use adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.

Disqualifiers

A history of cardiovascular disease (e.g., coronary artery disease, stroke, clinically significant congenital heart disease, clinically significant cardiac arrhythmias, and congestive heart failure);

History of glaucoma;

Current or recent (within 14 days of screening) use of a monoamine oxidase (MAO) inhibitor;

Any previous history of drug dependency or current use of an illicit substance (positive urine drug screen);

Trial design

Design model

Parallel

Treatments tested in this trial

Phentermine
Drug
Phentermine 16 mg administered orally once daily in the morning for 52 weeks. The dose is provided as two 8 mg tablets. Participants also receive lifestyle education handouts at each study visit. The intervention is designed to evaluate the efficacy and safety of phentermine for weight loss in adolescents with obesity.
Placebo
Drug
Placebo tablets that are visually identical to phentermine tablets but contain no active pharmaceutical ingredient. Administered orally once daily in the morning for 52 weeks. Participants also receive lifestyle education handouts at each study visit. This control arm is used to evaluate the efficacy and safety of phentermine in adolescents with obesity.

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: Phentermine 16 mg GroupExperimental treatment 1 intervention

Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Percent Change in BMI from Baseline at Week 52

Change in body mass index (BMI) expressed as a percentage of baseline BMI at week 52.

Time frame

52 weeks

Secondary outcomes

Number of Treatment-Emergent Adverse Events (TEAEs)

Count of TEAEs deemed probably or definitely related to study drug, including common side effects

Time frame

52 weeks

Number of Treatment-Emergent Adverse Events of Special Interest (TEAESIs)

Count of TEAESIs deemed probably or definitely related to study drug, including tachycardia, hypertension, depression, suicidality, and withdrawal symptoms

Time frame

52 weeks

Other outcomes

Changes in Cardiometabolic Risk Factor Waist Circumference

Change in waist circumference from baseline

Time frame

52 weeks

Changes in Cardiometabolic Risk Factor Blood Pressure

Change blood pressure from baseline

Time frame

52 weeks

Changes in Cardiometabolic Risk Factor Glucose

Change in glucose from baseline

Time frame

52 weeks

Changes in Cardiometabolic Risk Factor Lipids

Change in lipids from baseline

Time frame

52 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Russell McCulloh, MD

Lead sponsor

Heartland DCOC

Sponsor institution

National Institutes of Health (NIH)

Collaborator

IDeA States Pediatric Clinical Trials Network

Collaborator

Source ClinicalTrials.gov

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