---
title: "STEP 5: Semaglutide Phase 3 Results | Primara Labs"
url: https://www.primaralabs.com/research/trials/step-5
source: Primara Labs, markdown mirror of the HTML page
---

# STEP 5

In STEP 5, a phase 3 trial of semaglutide in adults with obesity, or overweight with at least one weight-related comorbidity, without diabetes (n=304), mean body weight fell 15.2% on 2.4 mg over 104 weeks, against 2.6% on placebo (treatment-policy estimand; Garvey WT et al. Nat Med 2022 (STEP 5)).

Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked.

Updated 24 September 2026

Semaglutide Explained: STEP, SUSTAIN and SELECT Trials (Philippines)2:07·[Transcript and chapters](https://www.primaralabs.com/videos/semaglutide)

## Results

Mean percent change in body weight by arm, as each source reports it. Navy bars are the trial arms, grey bars the comparator. Bars from different trials are not a head-to-head comparison: populations, durations and estimands differ.

## Side effects reported

In STEP 5, discontinuation because of adverse events was 5.9% on 2.4 mg, against 4.6% on placebo. The most frequently reported adverse events were gastrointestinal adverse events in 82.2% on 2.4 mg against 53.9% on placebo, nausea in 53.3% on 2.4 mg against 21.7% on placebo, diarrhoea in 34.9% on 2.4 mg against 23.7% on placebo and constipation in 30.9% on 2.4 mg against 11.2% on placebo.

| Event | 2.4 mg | Placebo |
| --- | --- | --- |
| Discontinuation for adverse events | 5.9% | 4.6% |
| Gastrointestinal adverse events | 82.2% | 53.9% |
| Nausea | 53.3% | 21.7% |
| Diarrhoea | 34.9% | 23.7% |
| Constipation | 30.9% | 11.2% |
| Vomiting | 30.3% | 4.6% |

Design

## Trial design and sources

Compound

Semaglutide

Phase

3

Population

Adults with obesity, or overweight with at least one weight-related comorbidity, without diabetes

Participants randomised

304

Duration

104 weeks

Primary endpoint

Co-primary: percentage change in body weight and achievement of weight loss of 5% or more at week 104

Estimand

treatment-policy

Read out

10 October 2022

-   Garvey WT et al. Nat Med 2022 (STEP 5) [open](https://doi.org/10.1038/s41591-022-02026-4) · checked 23 September 2026
-   ClinicalTrials.gov NCT03693430 [open](https://clinicaltrials.gov/study/NCT03693430) · checked 23 September 2026
-   Registry: NCT03693430

Questions

## STEP 5, answered

### What did STEP 5 find?

In STEP 5, a phase 3 trial of semaglutide in adults with obesity, or overweight with at least one weight-related comorbidity, without diabetes (n=304), mean body weight fell 15.2% on 2.4 mg over 104 weeks, against 2.6% on placebo (treatment-policy estimand; Garvey WT et al. Nat Med 2022 (STEP 5)).

### What side effects were reported in STEP 5?

In STEP 5, discontinuation because of adverse events was 5.9% on 2.4 mg, against 4.6% on placebo. The most frequently reported adverse events were gastrointestinal adverse events in 82.2% on 2.4 mg against 53.9% on placebo, nausea in 53.3% on 2.4 mg against 21.7% on placebo, diarrhoea in 34.9% on 2.4 mg against 23.7% on placebo and constipation in 30.9% on 2.4 mg against 11.2% on placebo.

Related

## More on semaglutide

-   [STEP 1](https://www.primaralabs.com/research/trials/step-1)
-   [STEP 2](https://www.primaralabs.com/research/trials/step-2)
-   [STEP 3](https://www.primaralabs.com/research/trials/step-3)
-   [STEP 4](https://www.primaralabs.com/research/trials/step-4)
-   [STEP 8](https://www.primaralabs.com/research/trials/step-8)
-   [SELECT](https://www.primaralabs.com/research/trials/select)
-   [SURMOUNT-5](https://www.primaralabs.com/research/trials/surmount-5)
-   [Evidence Map: Semaglutide](https://www.primaralabs.com/research/evidence#semaglutide)
-   [Semaglutide 15mg](https://www.primaralabs.com/marketplace/semaglutide-15mg)