---
title: "STEP 8: Semaglutide Phase 3b Results | Primara Labs"
url: https://www.primaralabs.com/research/trials/step-8
source: Primara Labs, markdown mirror of the HTML page
---

# STEP 8

In STEP 8, a phase 3b trial of semaglutide in US adults with BMI of 30 or greater, or 27 or greater with 1 or more weight-related comorbidities, without diabetes (n=338), mean body weight fell 15.8% on semaglutide 2.4 mg and 6.4% on liraglutide 3.0 mg over 68 weeks, against 1.9% on placebo (pooled) (treatment-policy estimand; Rubino DM et al. JAMA 2022 (STEP 8)).

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 8, discontinuation because of adverse events was 3.2% on semaglutide 2.4 mg and 12.6% on liraglutide 3.0 mg, against 3.5% on placebo (pooled). The most frequently reported adverse events were gastrointestinal disorders in 84.1% on semaglutide 2.4 mg and 82.7% on liraglutide 3.0 mg against 55.3% on placebo (pooled), nausea in 61.1% on semaglutide 2.4 mg and 59.1% on liraglutide 3.0 mg against 22.4% on placebo (pooled), constipation in 38.9% on semaglutide 2.4 mg and 31.5% on liraglutide 3.0 mg against 23.5% on placebo (pooled) and diarrhoea in 27.8% on semaglutide 2.4 mg and 18.1% on liraglutide 3.0 mg against 25.9% on placebo (pooled).

| Event | Semaglutide 2.4 mg | Liraglutide 3.0 mg | Placebo (pooled) |
| --- | --- | --- | --- |
| Discontinuation for adverse events | 3.2% | 12.6% | 3.5% |
| Gastrointestinal disorders | 84.1% | 82.7% | 55.3% |
| Nausea | 61.1% | 59.1% | 22.4% |
| Constipation | 38.9% | 31.5% | 23.5% |
| Diarrhoea | 27.8% | 18.1% | 25.9% |
| Vomiting | 25.4% | 20.5% | 5.9% |

Design

## Trial design and sources

Compound

Semaglutide

Phase

3b

Population

US adults with BMI of 30 or greater, or 27 or greater with 1 or more weight-related comorbidities, without diabetes

Participants randomised

338

Duration

68 weeks

Primary endpoint

Percentage change in body weight, semaglutide vs liraglutide at week 68

Estimand

treatment-policy

Read out

1 January 2022

Semaglutide against liraglutide was open-label; each was blinded against its own placebo, pooled.

-   Rubino DM et al. JAMA 2022 (STEP 8) [open](https://doi.org/10.1001/jama.2021.23619) · checked 23 September 2026
-   ClinicalTrials.gov NCT04074161 [open](https://clinicaltrials.gov/study/NCT04074161) · checked 23 September 2026
-   Registry: NCT04074161

Questions

## STEP 8, answered

### What did STEP 8 find?

In STEP 8, a phase 3b trial of semaglutide in US adults with BMI of 30 or greater, or 27 or greater with 1 or more weight-related comorbidities, without diabetes (n=338), mean body weight fell 15.8% on semaglutide 2.4 mg and 6.4% on liraglutide 3.0 mg over 68 weeks, against 1.9% on placebo (pooled) (treatment-policy estimand; Rubino DM et al. JAMA 2022 (STEP 8)).

### What side effects were reported in STEP 8?

In STEP 8, discontinuation because of adverse events was 3.2% on semaglutide 2.4 mg and 12.6% on liraglutide 3.0 mg, against 3.5% on placebo (pooled). The most frequently reported adverse events were gastrointestinal disorders in 84.1% on semaglutide 2.4 mg and 82.7% on liraglutide 3.0 mg against 55.3% on placebo (pooled), nausea in 61.1% on semaglutide 2.4 mg and 59.1% on liraglutide 3.0 mg against 22.4% on placebo (pooled), constipation in 38.9% on semaglutide 2.4 mg and 31.5% on liraglutide 3.0 mg against 23.5% on placebo (pooled) and diarrhoea in 27.8% on semaglutide 2.4 mg and 18.1% on liraglutide 3.0 mg against 25.9% on placebo (pooled).

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 5](https://www.primaralabs.com/research/trials/step-5)
-   [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)
