From the Guidelines
FDA-approved weight loss medications, including Zepbound (tirzepatide), are generally approved for adults 18 years and older, with limited options available for adolescents and no approvals for children under 12 years old. The age limitations for usage of these medications are primarily based on the availability of clinical trial data and considerations of safety and efficacy in different age groups 1.
Age Restrictions for Weight Loss Medications
- Most weight loss medications, including Zepbound, are approved for adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related condition.
- For adolescents, options are more limited, with orlistat (Xenical) approved for ages 12-17, and phentermine-topiramate (Qsymia) approved for ages 12 and older.
- Wegovy (semaglutide) has recently received approval for use in children aged 12 and older with obesity.
- No weight loss medications are approved for children under 12 years old, as clinical trials have primarily focused on adult populations, with limited data on safety and efficacy in younger individuals 1.
Considerations for Prescribing Weight Loss Medications
- Clinicians should consider pharmacotherapy in combination with lifestyle therapy for adults with a BMI ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 with at least one obesity-related complication 1.
- The choice of obesity medication should be made with respect to the individual's clinical characteristics and the country-specific approved labeling of the available products 1.
- Experienced clinicians may consider antiobesity pharmacotherapy as an adjunct to lifestyle interventions for adolescents with more severe obesity and inadequate weight loss 1.
From the Research
Age Limitations for FDA-Approved Weight Loss Medications
The age limitations for usage of FDA-approved weight loss medications, including Zepbound (tirzepatide), are not explicitly stated in the provided studies. However, the studies do provide information on the age range of participants in the clinical trials.
- The study published in The New England Journal of Medicine 2 included adults with a body-mass index (BMI) of 30 or more, or 27 or more and at least one weight-related complication, excluding diabetes. The mean age of the participants was not specified.
- The systematic review and meta-analysis published in Obesity Reviews 3 included six randomized trials on individuals with overweight or obesity, without diabetes mellitus. The age range of the participants was not specified.
- The review published in Drugs 4 discussed the approval of tirzepatide for use as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The age range for approval was not specified.
- The mini-review published in Molecules 5 discussed the dual-targeted treatment for diabetes and obesity using tirzepatide. The age range for usage was not specified.
- The narrative review published in Journal of Clinical Medicine 6 analyzed the effects on body weight of discontinuing therapy with glucagon-like peptide-1 receptor agonists or tirzepatide in patients treated for obesity. The age range of the participants was not specified, but the review was restricted to randomized controlled trials in adults (19+ years).
Key Points
- The age limitations for usage of FDA-approved weight loss medications, including Zepbound (tirzepatide), are not explicitly stated in the provided studies.
- The clinical trials included adults with a BMI of 30 or more, or 27 or more and at least one weight-related complication, excluding diabetes.
- The age range of the participants in the clinical trials was not specified, but the reviews were restricted to randomized controlled trials in adults (19+ years).
- Further research is needed to determine the optimal age range for usage of FDA-approved weight loss medications, including Zepbound (tirzepatide) 2, 3, 4, 5, 6.