Over the past year, indications for anti-obesity medications (AOM) have shifted from strict BMI cut-offs to broader, more inclusive criteria. In this blog, we will review the FDA-approved labeling for both pediatric and adult AOM, highlighting how these updates may appear on the exam. Additionally, we will discuss updated AOM indications and approvals for targeting obesity-related comorbidities.

Previously, FDA indications for AOM applied to individuals with a BMI of 27 kg/m² plus an adiposity-based chronic disease (such as dyslipidemia or diabetes) or to anyone with a BMI greater than 30 kg/m². Off-label prescribing allowed for flexibility, though insurance coverage often remained limited to FDA labelling. This also posed challenges for patients whose BMI thresholds differed by ethnicity. For example, individuals of Asian descent, who meet criteria for obesity at a lower absolute BMI, were not included under the previous FDA labeling. In addition, a bodybuilder with high muscle mass and minimal body fat may have met criteria for an AOM, while another patient with increased waist circumference and higher adiposity-related cardiac risk may not. BMI is a useful screening tool for the general population but does not always reflect an individual patient’s true health profile.

However, now the labeling has transitioned from BMI cutoffs to categorization. For example, let’s take a look at Qsymia® (phentermine/topiramate ER) labeling. This medication is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in:

  • Adults and pediatric patients aged 12 years and older with obesity
  • Adults with overweight in the presence of at least one weight-related comorbid condition

These same weight-based criteria mirror Wegovy® (semaglutide) indications. Similarly, Zepbound® (tirzepatide), Contrave® (naltrexone/bupropion ER), and Foundayo® (orforglipron) follow the same criteria, but exclude the pediatric population.

So, what’s the significance of this labelling change?

  • Decreased BMI threshold: Patients with a BMI of 25 kg/m² plus an adiposity-related chronic disease (ABCD) now meet criteria for treatment, compared with the previous cutoff of 27 kg/m².
  • Ethnicity-specific inclusion: Patients of Asian descent may now qualify for treatment at a BMI of 23 kg/m² with an ABCD or 25 kg/m², reflecting ethnicity-adjusted thresholds.
  • Alternative anthropometric measures: With newer, disease-based frameworks, treatment eligibility expands beyond BMI alone, allowing additional measures such as waist circumference and body fat percentage to help identify excess adiposity and guide management of overweight and obesity.
  • Weight maintenance: Previously, patients who successfully reduced their weight sometimes lost insurance coverage eligibility if their BMI normalized (e.g., a patient with BMI 30 kg/m² who lost weight). This approach was inconsistent with treatment for other chronic conditions, such as hypertension. This subtle wording change is important, emphasizing long-term weight reduction maintenance, reducing recertification denial from insurance coverage.

Do these changes increase patient eligibility for insurance coverage of anti‑obesity medications? Not at all. In fact, insurance companies often incorporate AOM into plan exclusions, removing coverage regardless of indications. However, if a patient otherwise qualifies for AOM and have insurance coverage, insurers should no longer deny coverage based solely on historic FDA BMI indications. Unfortunately, insurance companies will likely find alternative means of denials and road blocks. However, on the ABOM exam, these updated criteria increase eligibility for treatments.

In addition to the weight‑categorization–based indication eligibility, there have been a number of recent changes to dosing, formulary, and ABCD indications that are important to note:

  • Zepbound® (tirzepatide) also picked up FDA approval for moderate to severe obstructive sleep apnea in adults with obesity in December 2024. Additionally, it is now available in a multi-dose KwikPen format, where one pen lasts for four weekly doses, improving convenience compared to single-dosing pens.
  • Wegovy® (semaglutide) gained major adverse cardiovascular event approval in March 2024 to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and obesity/overweight. It later received accelerated FDA approval for MASH with stage 2/3 fibrosis in August 2025. Novo Nordisk has also secured approval for higher dosing with a 7.2 mg once-weekly subcutaneous formulation, representing an expansion beyond the prior 2.4 mg dose. In addition, the first oral formulation of semaglutide for weight management was approved in December 2025.
  • Imcivree® (setmelanotide) gained an FDA-approved indication for acquired hypothalamic obesity (e.g., following hypothalamic injury) in those ≥4 years of age. In addition, the approved age range for specific genetic etiologies of obesity, such as Bardet-Biedl syndrome and POMC, PCSK1, or LEPR deficiency, has been expanded from ≥6 years down to ≥2 years of age.
  • Vykat XR® (diazoxide choline extended-release) gained an FDA-approved indication for hyperphagia associated with Prader-Willi syndrome in individuals ≥4 years of age. This approval represents the first medication specifically indicated to address the hallmark hyperphagia and food-seeking behaviors seen with this condition.
  • Foundayo® (orforglipron) gained FDA approval for chronic weight management this week (April 2026). As a once-daily, oral, non-peptide GLP-1 receptor agonist, it represents the first small-molecule GLP-1 therapy for obesity that can be taken without food or timing restrictions. Clinical trial data from the ATTAIN program demonstrated significant and sustained weight loss of approximately 10–12% compared to placebo, along with improvements in cardiometabolic risk factors.

It is exciting to see so many updates and changes in anti-obesity medications, and this momentum is unlikely to slow anytime soon. The more tools we have in our arsenal to treat both obesity and its associated chronic diseases, the greater the benefit for our patients. Be familiar with these updates both clinically and for the exam. Although it may take time for new information to appear on board exams, questions should not contradict the most up-to-date evidence.

Sample Question

A Caucasian man with dyslipidemia presents to clinic to discuss pharmacologic treatment for weight management. Based on current FDA-approved indications, what is the minimum BMI at which he would qualify for pharmacotherapy?

A. 23 kg/m²
B. 25 kg/m²
C. 27 kg/m²
D. 30 kg/m²

Next Week: POMC deficiency

Upcoming: Tirzepatide Studies/Trials and Built Environment

For more practice questions, check out the following:

  • Obesity Medicine Board Review Questions (2026): Q 211.
  • Obesity Medicine Practice Tests (2026): Qs 142 and 191.

(Copyright 2026) Obesity Medicine Board Review Questions, LLC: obesitymedicinereview.com

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Copyediting by Kelly Smith

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