Semaglutide 2.4 mg achieves 14.9% mean weight loss in STEP 1

What was reported

Semaglutide 2.4 mg achieves 14.9% mean weight loss in STEP 1 — a Clinical trial registry and NEJM publication readout reported by Novo Nordisk A/S on Mar 18, 2021. Linked to trial NCT04184622.

Related entities

Assets

Semaglutide

Companies

Novo Nordisk

Design

Double-blind, placebo-controlled phase 3 trial of semaglutide 2.4 mg vs placebo over 68 weeks in adults with obesity.

Primary endpoint

Percent change in body weight from baseline to week 68

Result

Mean weight loss of 14.9% with semaglutide 2.4 mg vs 2.4% with placebo.

Missing data

Multiple imputation used for missing weight data; sensitivity analyses consistent.

Caveats

Trial excluded patients with recent cardiovascular events; SELECT powered separately for MACE.

Comparison

Results supported Wegovy approval and pricing assumptions.

Pipeline changes

Expanded obesity franchise and drove Cagrisema combination development.

Unknowns

Long-term durability and real-world adherence remain active questions.

Comparator

Placebo

Effect size

Odds ratio for ≥5% weight loss was approximately 10.8.

Discontinuations

Treatment discontinuation due to adverse events was 7.0% with semaglutide vs 3.1% placebo.

Adverse events

Nausea, diarrhea, vomiting most common; gallbladder disorders and injection-site reactions reported.