Is Zepbound (tirzepatide) approved for weight loss?

Tirzepatide (Zepbound) Approval for Weight Loss

Yes, tirzepatide (Zepbound) is FDA-approved for weight management in adults with obesity or overweight with at least one weight-related condition. 1

Approval and Indications

Tirzepatide is approved under two brand names:

• Zepbound: Specifically approved for chronic weight management
• Mounjaro: Approved for type 2 diabetes management

The FDA approval for weight management applies to adults with:

• BMI ≥30 kg/m² (obesity), or
• BMI ≥27 kg/m² with at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes) 1

Efficacy for Weight Loss

Tirzepatide demonstrates remarkable efficacy for weight loss:

• Produces mean weight reduction of 8.47 kg compared to usual care 2
• Up to 67% of participants achieve ≥10% weight reduction at higher doses 2, 1
• Average weight reduction of 15% at 72 weeks with the 5 mg maintenance dose 1
• Higher doses (10-15 mg) can achieve even greater weight loss (16.5-22.4%) 3

This efficacy exceeds that of other weight loss medications:

• Semaglutide: 21% of participants achieve ≥10% weight reduction
• Liraglutide: 15.9-25.2% of participants achieve ≥10% weight reduction
• Other GLP-1 agonists: Mean weight reduction of 2.22 kg compared to usual care 1

Dosing Protocol

The FDA-approved dosing protocol for Zepbound is:

1. Initial dose: 2.5 mg subcutaneously once weekly for 4 weeks
2. First maintenance dose: 5 mg once weekly for at least 4 weeks
3. Further titration as tolerated: 7.5 mg → 10 mg → 12.5 mg → 15 mg (maximum) 1

Side Effects and Management

The most common adverse effects are gastrointestinal:

• Nausea, vomiting, diarrhea, and bloating 1

To minimize these side effects:

• Start at the low dose and titrate slowly
• Reduce meal size
• Avoid high-fat foods
• Limit alcohol and carbonated drinks
• Take medication on the same day each week 1

Important Considerations

1. Contraception: Women using oral hormonal contraceptives should use or add a non-oral method for 4 weeks after initiation and after each dose escalation 1

2. Medication interactions: Monitor for delayed absorption of oral medications with narrow therapeutic index 1

3. Long-term treatment: Weight regain is likely if tirzepatide is discontinued, suggesting the need for long-term treatment 1

4. Additional benefits: Beyond weight loss, tirzepatide may improve:

   • Cardiovascular risk factors (blood pressure, lipids)
   • Obstructive sleep apnea
   • Metabolic-associated steatotic liver disease
   • Heart failure symptoms 1, 4

5. Pharmacokinetics: Tirzepatide has a half-life of approximately 5 days, enabling once-weekly dosing 5

In conclusion, tirzepatide (Zepbound) represents a significant advancement in pharmacological weight management, offering substantial weight loss benefits with a safety profile similar to other GLP-1 receptor agonists.