Is Ozempic (semaglutide) FDA approved for weight loss?

Is Ozempic FDA Approved for Weight Loss?

No, Ozempic (semaglutide) is not FDA approved for weight loss. While semaglutide is available in a higher dose formulation called Wegovy (2.4 mg) that is FDA approved for chronic weight management, Ozempic itself is only FDA approved for the treatment of type 2 diabetes 1.

FDA Approval Status of Semaglutide Products

Ozempic (Semaglutide Injection)

• FDA approved indication: Treatment of type 2 diabetes
• Dosage: Available in doses up to 1 mg or 2 mg weekly
• Not approved for weight management

Wegovy (Semaglutide 2.4 mg)

• FDA approved indication: Chronic weight management in adults with:
  • BMI ≥30 kg/m² (obesity) OR
  • BMI ≥27 kg/m² (overweight) with at least one weight-related comorbid condition
• Approved as an adjunct to: Reduced calorie diet and increased physical activity

Clinical Evidence on Semaglutide for Weight Management

The FDA approval of semaglutide 2.4 mg (Wegovy) for weight management was based on the STEP (Semaglutide Treatment Effect in People with obesity) clinical trial program 2, 3:

• STEP 1-4 trials demonstrated that semaglutide 2.4 mg achieved significant and sustained weight loss
• In patients without type 2 diabetes, mean weight loss ranged from 14.9% to 16.0% of baseline weight over 68 weeks 2
• This exceeds the weight loss typically seen with other approved anti-obesity medications (4.0% to 10.9%) 2

Common Pitfalls in Prescribing Practice

1. Off-label prescribing confusion: Many clinicians have prescribed Ozempic off-label for weight loss, despite it not being FDA-approved for this indication 4

2. Insurance coverage issues: This off-label use has contributed to supply shortages, making it difficult for patients with diabetes to obtain their needed medications 4

3. Dosage differences: The weight management dose of semaglutide (2.4 mg weekly) is higher than the maximum dose approved for Ozempic in diabetes treatment 1

Clinical Implications

• For patients seeking weight management medication, the appropriate FDA-approved formulation is Wegovy (semaglutide 2.4 mg), not Ozempic 1

• For patients with both obesity and type 2 diabetes:

  • Guidelines recommend prioritizing medications with beneficial effects on weight 1
  • GLP-1 receptor agonists like semaglutide or the dual GIP/GLP-1 receptor agonist tirzepatide are preferred options 1
  • These medications provide both glycemic control and weight management benefits

• For patients with obesity but without diabetes:

  • Wegovy (semaglutide 2.4 mg) is FDA-approved for chronic weight management
  • Should be used as an adjunct to reduced calorie diet and increased physical activity

Safety Considerations

Common adverse effects of semaglutide include 1:

• Gastrointestinal effects (nausea, vomiting, diarrhea, constipation)
• Potential increased risk of pancreatitis and gallbladder disease
• Contraindicated in pregnancy and not recommended during breastfeeding
• Contraindicated in patients with personal/family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2

In summary, while semaglutide has proven efficacy for weight management, Ozempic specifically is not FDA approved for this purpose. The appropriate FDA-approved formulation for weight management is Wegovy (semaglutide 2.4 mg).