Phentermine/Topiramate as Preventive Pharmacotherapy for Obesity

NCT05834062 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: PEDS-2022-31025
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the use of phentermine and topiramate compared with placebo in helping adolescents who are at high risk for developing obesity to lose weight

Conditions

Obesity, Adolescent

Outcome Measures

Primary Outcomes (1)

• Evaluate effects of preventive pharmacotherapy and lifestyle-based weight gain prevention on body mass index between the medication arm and the placebo arm

  Change in BMI

  24 months

Study Arms (2)

Medication arm

EXPERIMENTAL

Individuals randomized to this group will be offered lifestyle-based weight gain prevention counseling. Participants will initiate treatment at 3.75 mg/23 mg orally once in the morning for 14 days, which will then be increased to 7.5 mg/46 mg orally once daily in the morning for the remainder of the trial. Participants who are unable to tolerate the dosing regimen will be maintained at the maximally tolerated dose. To further safeguard the risk/benefit balance we will utilize a down-titration protocol for participants who experience a reduction in BMI below a threshold of 20 kg/m2. In this case, participants will be reduced to the lowest-dose level (3.75 mg/23 mg) for 12 weeks. If the BMI remains below 20 kg/m2 at the lowest dose after 12 weeks, active treatment will be fully withdrawn. Participants at the end of the study will be down-titrated gradually with instructions to take the medication every other day for 7 days before stopping treatment altogether.

Drug: Qsymia and lifestyle management therapy

Placebo arm

PLACEBO COMPARATOR

Individuals randomized to this group will be offered lifestyle-based weight gain prevention counseling. Participants will initiate treatment with a placebo (to keep the blind) and be asked to up-titrate the placebo dose after the first 14 days and then maintain the placebo dose for the remainder of the study. Individuals who are unable to tolerate the dosing regimen will have a down-titration protocol (to maintain the blind) as described in the medication arm. Likewise, we will employ a down-titration protocol for participants who experience a reduction in BMI below a threshold of 20 kg/m2. In this case, participants would be reduced to the lowest dose level of placebo for 12 weeks. If the BMI remains below 20 kg/m2 after 12 weeks, placebo treatment will be fully withdrawn. Individuals in the placebo arm will also have a placebo-based down-titration with instructions to take the placebo every other day for 7 days before stopping treatment altogether, to maintain the blind.

Behavioral: Placebo and lifestyle management therapy

Interventions

Qsymia and lifestyle management therapy DRUG

Qsymia will be used at 3.7g mg/23 mg for 12 weeks and then increased to 7.5 mg/46 mg for the remainder of the study. Participants will be offered lifestyle management therapy.

Medication arm

Placebo and lifestyle management therapy BEHAVIORAL

Placebo will be used in lieu of Qsymia to maintain the blind. Participants will be offered lifestyle management therapy.

Placebo arm

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 16 to less than 22 years at screening
• BMI \>/= 25 to \< 30 kg/m\^2
• Family history of obesity defined as one biological parent with severe obesity (BMI \>/= 35) and/or two biological parents with obesity (BMI \>/= 30)
• Age 16 or 17 years old must also have an obesity-related complication/co-morbidity defined as elevated blood pressure (\>/= 130 and/or \>/= 80 milligrams of mercury \[mmHg\]) or current use of anti-hypertensive medication, dyslipidemia (triglycerides \>/= 150 milligrams/deciliter (mg/dL) and/or HDL cholesterol \< 40 mg/dL or current use of cholesterol-lowering medication, diagnosis of obstructive sleep apnea

You may not qualify if:

• Tanner stage 1-4
• Diabetes (1 or 2)
• Current or recent (\< 6 months prior to enrollment) use of anti-obesity medication(s) and other weight-altering medication(s) (e.g.,, atypical antipsychotics, attention-deficit hyperactivity disorder \[ADHD\] stimulant)
• Previous bariatric surgery
• Current or recent (\< 6 months prior to enrollment) use of medication(s) to treat insulin resistance
• Recent initiation (\< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s)
• History of glaucoma
• Current or recent (\< 14 days) use of monoamine oxidase inhibitor
• Known hypersensitivity to sympathomimetic amines
• History of treatment with growth hormone
• Patient Health Questionnaire (PHQ) score of \>/= 15
• Eating disorder symptoms within 6 months and/r any past medical diagnosis of eating disorder
• Major psychiatric disorder
• Unstable clinically-diagnosed depression
• History of suicide attempt

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Qsymia

Condition Hierarchy (Ancestors)

Obesity; 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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: April 28, 2023
• Study Start: October 17, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

US (1)