Pharmacotherapy for Pediatric Obesity: A Phentermine Clinical Trial

• Status: Withdrawn
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-site, randomized, placebo-controlled clinical trial to examine the weight loss efficacy and cardiovascular safety of phentermine 15 mg daily plus lifestyle therapy versus placebo plus lifestyle therapy among 200 adolescents ages ≥10 to <18 years with obesity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota

Criteria

Inclusion Criteria:

• Stated willingness to comply with all study procedures and availability for the duration of the study.

• Male or female, aged 10-<18 years

• BMI ≥ 95th age- and sex-specific Centers for Disease Control (CDC) percentile

• Tanner stage ≥ 1

• Ability to take oral medication and be willing to adhere to the lifestyle therapy regimen

Exclusion Criteria:

• Contraindications to phentermine including: history of cardiovascular disease (including coronary artery disease, stroke, clinically significant congenital heart disease, clinically significant cardiac arrhythmias, congestive heart failure); glaucoma; current or recent (<14 days) use of MAO inhibitors; history of or current chemical dependency; current pregnancy or plans to be pregnant during course of study or lactation; known hypersensitivity to sympathomimetic amines.

• Hypertension

• Cardiac pacemaker

• Type 1 or type 2 diabetes mellitus

• Current or recent (<6 months prior to enrollment) use of weight loss medication(s)

• Current use of other sympathomimetic amines such as ADHD stimulants

• History of bariatric surgery

• Schizophrenia, psychosis, or mania

• Any history of suicide attempt

• Self-harm within 12 months prior to screening

• PHQ-9 score of ≥15 at screening

• Suicidal ideation of type 4 or 5 on C-SSRS in past month

• Hyperthyroidism