Pharmacotherapy for Pediatric Obesity: A Phentermine Clinical Trial

NCT04678323 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: CPOM-P01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity, Childhood

Keywords

Obesity

Outcome Measures

Primary Outcomes (2)

• Change in body mass index (BMI)

  To determine the effect of phentermine vs. placebo on body mass index reduction

  52 weeks

• Change in systolic and diastolic blood pressure

  To determine the effect of phentermine vs. placebo on systolic and diastolic blood pressure

  52 weeks

Secondary Outcomes (4)

• Change in triglyceride/HDL ratio

  52 weeks

• Change in inflammation

  52 weeks

• Change in oxidative stress

  52 weeks

• Change in Quality of Life

  52 weeks

Study Arms (2)

Phentermine Plus Lifestyle Therapy

ACTIVE COMPARATOR

Participants in this arm will receive 15 mg p.o.q.day of phentermine plus lifestyle therapy for 52 weeks.

Drug: Lifestyle Management

Placebo Plus Lifestyle Therapy

PLACEBO COMPARATOR

Participants in this arm will receive a matching placebo plus lifestyle therapy for 52 weeks.

Drug: Lifestyle Management

Interventions

Lifestyle Management DRUG

Participants in this group will receive lifestyle management.

Phentermine Plus Lifestyle Therapy; Placebo Plus Lifestyle Therapy

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will randomize participants in a 1:1 manner to receive phentermine plus lifestyle therapy or placebo plus lifestyle therapy.

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 21, 2020
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 5, 2021

Record last verified: 2021-07