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Intermittent Phentermine for Obesity and Body Composition
Sponsor: OSCAR MANUEL TORRES FALCON
Summary
This study evaluated the effects of intermittent phentermine treatment on body fat, estimated visceral adiposity, body composition, and tolerability in adults with overweight or obesity. A total of 600 adults aged 21 to 40 years with a body mass index (BMI) between 27 and 35 kg/m² participated in a single-center, randomized, four-group clinical trial conducted at Hospital Médica Campestre in León, Guanajuato, Mexico. Participants were assigned to lifestyle modification alone or lifestyle modification combined with phentermine at doses of 15 mg, 30 mg, or 37.5 mg daily. Phentermine was administered intermittently using a schedule of three months of treatment followed by one month without medication during a 14-month observation period. All participants received nutritional guidance and physical activity recommendations. Body composition was assessed using bioelectrical impedance analysis and three-dimensional body scanning. The primary outcome was the relative percentage reduction in total body fat from baseline to Month 14. Secondary outcomes included estimated visceral adiposity, waist circumference, lean body mass, body weight, BMI, medication adherence, resting heart rate, blood pressure, treatment-emergent adverse events, and treatment discontinuation. The study aimed to evaluate the dose-response effects of intermittent phentermine on body composition and the balance between efficacy and tolerability.
Official title: Adaptive Pharmacotherapy in Obesity: Intermittent Phentermine Improves Visceral Adiposity and Body Composition
Key Details
Gender
All
Age Range
21 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2024-03-01
Completion Date
2026-01-15
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Phentermine 15 MG
Oral phentermine hydrochloride 15 mg administered once daily during active-treatment periods using a planned intermittent schedule of 3 months on treatment followed by 1 month off treatment, repeated over the 14-month observation period, in combination with structured lifestyle treatment.
Phentermine 30 mg
Oral phentermine hydrochloride 30 mg administered once daily during active-treatment periods using a planned intermittent schedule of 3 months on treatment followed by 1 month off treatment, repeated over the 14-month observation period, in combination with structured lifestyle treatment.
Phentermine 37.5 Mg
Oral phentermine hydrochloride 37.5 mg administered once daily during active-treatment periods using a planned intermittent schedule of 3 months on treatment followed by 1 month off treatment, repeated over the 14-month observation period, in combination with structured lifestyle treatment.
Lifestyle Management
Structured lifestyle treatment targeting an energy deficit of approximately 500 kcal/day and approximately 150 minutes/week of aerobic physical activity.
Locations (1)
Hospital Medica Campestre
León, Guanajuato, Mexico