Phentermine's Impact on Treatment in Teens

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
Russell McCulloh, MD
Study ID
NCT07282340
Phase
PHASE2
Status
Recruiting
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Conditions

  • Childhood Obesity

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 3, 2026
Status verified
Nov 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phentermine 16 mg Group
    Participants in this arm will receive phentermine 16 mg daily, administered as two 8 mg tablets taken orally once
  • Placebo Comparator: Placebo Group
    Participants in this arm will receive placebo tablets that are visually identical to the phentermine tablets but contain no active pharmaceutical ingredient. The placebo will be taken orally once daily in the morning for 52 weeks. All participants will also receive lifestyle education handouts at each study visit. This arm serves as the control group for evaluating the efficacy and safety of phentermine in adolescents with obesity.

Primary Outcome Measure

Percent Change in BMI from Baseline at Week 52 [ Time Frame: 52 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of New Mexico Health Sciences CenterAlbuquerqueNew Mexico87131
Arielle Padilla, RN
[email protected]
(505) 272-1972
Michele Hutchison, MD (PRINCIPAL_INVESTIGATOR)
Prisma Health-Midlands Children's HospitalColumbiaSouth Carolina29203
Page Wiggins
[email protected]
803-434-8977
Lisa Knight, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of New Mexico Health Sciences Center· Albuquerque, NMPrisma Health-Midlands Children's Hospital· Columbia, SC

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