NCT07870668|CompletedPhase 4
Intermittent Phentermine for Obesity and Body Composition
Adaptive Pharmacotherapy in Obesity: Intermittent Phentermine Improves Visceral Adiposity and Body Composition
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Adaptive Pharmacotherapy in Obesity: Intermittent Phentermine Improves Visceral Adiposity and Body Composition
Sponsor study identifier
interventional
600
1 country
1
Study Start
March 1, 2024
Actual (reported)Primary Completion
January 15, 2026
Actual (reported)Study Completion
January 15, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 15, 2026
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2024
Actual (reported)January 15, 2026
Actual (reported)January 15, 2026
Actual (reported)October 6, 2026
Actual (reported)October 13, 2026
Actual (reported)Relative Percentage Reduction in Total Body Fat from Baseline
Relative percentage reduction in total body fat from baseline to Month 14, calculated as 100 × (baseline value - Month 14 value) / baseline value.
Baseline through Month 14
Relative Percentage Reduction in Estimated Visceral Adiposity from Baseline
Baseline and 14 months
Change in Lean Body Mass from Baseline
Baseline and 14 months
Change in Body Weight from Baseline
Baseline and 14 months
Treatment-Emergent Adverse Events.
Baseline through Month 14
Waist Circumference
Baseline to Month 14
Participants received structured lifestyle treatment targeting an energy deficit of approximately 500 kcal/day and approximately 150 minutes/week of aerobic physical activity, without phentermine administration.
Participants received oral phentermine hydrochloride 15 mg 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.
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.
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.
Hospital Medica Campestre
León, Guanajuato, 37180, Mexico
600 participants (actual enrollment reported by the registry).
First Submitted
October 6, 2026
Participants received oral phentermine hydrochloride 30 mg 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.
Participants received oral phentermine hydrochloride 37.5 mg 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.
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.
Structured lifestyle treatment targeting an energy deficit of approximately 500 kcal/day and approximately 150 minutes/week of aerobic physical activity.
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First Posted
October 13, 2026
Study Start
March 1, 2024
Actual (reported)Primary Completion
January 15, 2026
Actual (reported)Study Completion
January 15, 2026
Actual (reported)Last Updated
October 13, 2026
Record last verified: 2026-10
Deidentified individual participant-level data underlying the reported results, together with a data dictionary, may be shared with qualified researchers after publication.
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Source: ClinicalTrials.gov.
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