Phentermine/Topiramate as Preventive Pharmacotherapy for Obesity

• Status: Not yet recruiting
• Trial end date: 2027-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last month

• Current pregnancy or breastfeeding

• Plans to become pregnant

• If sexually active, refusal to use 2 forms of birth control

• Tobacco use

• Alanine transaminase (ALT ) or Aspartate transaminase (AST) >/= 2.5 the upper limit of normal

• Bicarbonate < 18 micromoles per liter (mmol/L)

• Creatinine 1.2 mg/dL

• Creatinine clearance of < 50 microliters per minute [mL/min] (Schwartz formula)

• History of seizures

• Uncontrolled hypertension

• History of structural heart defect

• History of clinically significant arrhythmia

• Diagnosed monogenic obesity

• History of cholelithiasis

• History of nephrolithiasis

• Hyperthyroidism

• Untreated thyroid disorder