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Phentermine's Impact on Treatment in Teens

NCT07282340 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-12-15

No results posted yet for this study

Summary

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.

Conditions

  • Childhood Obesity

Interventions

DRUG

Phentermine

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • IDeA States Pediatric Clinical Trials Network

    collaborator NETWORK

  • Russell McCulloh, MD

    lead NETWORK

Principal Investigators

  • Russell McCulloh, MD · UNMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2028-01-31
Completion
2028-01-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282340 on ClinicalTrials.gov