• 27 Nov 2025
• Admin
• News Article

Novo Nordisk Fast-Tracks a Higher-Dose Semaglutide Injection for Obesity: What You Need to Know

Obesity care is shifting fast, and Novo Nordisk just pushed the accelerator again.
The company has submitted a supplemental NDA for a new 7.2 mg semaglutide injection, designed to deliver greater weight-loss outcomes for adults with obesity.

The application will be reviewed under the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot — an expedited review program for urgent national health priorities.

Why This New Dose Matters?

If approved, the 7.2 mg dose will give clinicians an additional option when managing obesity.
And early data shows why it matters.

Key Highlights

• The 7.2 mg dose offers higher weight-loss potential than the current 2.4 mg dose.
• Review under the CNPV pilot means a faster pathway, with FDA feedback expected 1–2 months after filing acceptance.
• The dose will be used with diet changes and increased physical activity, similar to current chronic weight-management protocols.

Novo Nordisk’s SVP Anna Windle calls this submission “an exciting step forward,” especially for people needing stronger clinical response.

What STEP UP Trial Revealed?

The submission is backed by STEP UP, a large 72-week, phase 3 trial including 1,407 adults with obesity and no diabetes.

Weight-Loss Results (Adherent Population)

• 20.7% average weight loss with semaglutide 7.2 mg
• 17.5% with semaglutide 2.4 mg
• 2.4% with placebo

From a baseline of 249 pounds, the 7.2 mg dose delivered stronger and more consistent reductions.

Deep Dive: Percentage Achieving Major Weight-Loss Milestones

• 25% weight loss:
  - 7.2 mg → 33.2%
  - 2.4 mg → 16.7%
  - Placebo → 0%

Results Including People Who Discontinued Treatment

• 7.2 mg → 18.7% weight loss
• 2.4 mg → 15.6%
• Placebo → 3.9%

5% Weight-Loss Achievement

• 7.2 mg → 90.7%
• 2.4 mg → 89.9%
• Placebo → 36.8%

This trial confirms something clear: higher dose = meaningfully higher outcomes.

Safety Snapshot

Gastrointestinal side effects were more common with the 7.2 mg dose. Dysaesthesia was also higher. Serious adverse events occurred in:

• 6.8% (7.2 mg)
• 10.9% (2.4 mg)
• 5.5% (placebo)

Safety remains consistent with what clinicians expect from GLP-1–based therapies.

Global Regulatory Status

The 7.2 mg dose of Wegovy® is also under review in:

• The EU
• The UK
• Several other regions

A European regulatory decision is expected in Q1 2026.

Quick Background on STEP UP

The trial was:

• 72 weeks
• Randomized, double-blind
• Placebo- and active-controlled
• Designed to evaluate superiority on weight change and ≥5% weight-loss response

It also assessed deeper endpoints like 10%, 15%, 20%, and 25% weight loss.

Why Obesity Treatment Needs These Options

Obesity is not a willpower issue. It is a chronic, progressive, biology-driven disease that requires long-term management. Genetics, environment, and social factors all play a role.

Options like semaglutide 7.2 mg broaden the clinical toolkit needed to manage this complexity.

About Novo Nordisk

Novo Nordisk has spent over 100 years advancing diabetes and obesity care.
The company now operates in about 170 countries and employs over 78,000 people worldwide.

Its mission is simple: Defeat chronic disease through science, access, and long-term solutions.