“Were Women Studied?” audit

STEP-1 (NCT03548935)

Women were well represented in the semaglutide weight-management trials, but prespecified sex analyses had limited precision.

Representation grade

Target population represented

Sex-analysis grade

Prespecified, limited precision

Representation level

Target population represented with useful denominator detail

Basis: STEP-1 enrolled 1,961 participants, of whom about 63% were female.

Sex-analysis level

Prespecified analysis reported but limited precision/power

Population and enrollment

Enrollment breakdown

Terminology in source: Sex (female/male) per the NEJM publication.

0.0%

women / female participants

0 of 0 enrolled

Women (1,239)

Other (722)

Population definition

Adults with obesity or overweight without diabetes.

Age distribution

—

Inclusion and exclusion by life stage

Pregnancy exclusion

—

Lactation exclusion

—

Reproductive-potential requirements

—

Age/life-stage data

—

Sex-analysis plan and findings

Prespecified sex analysis

Yes

Powered for sex analysis

No / unclear

Interaction test reported

No / unclear

Efficacy by sex

Prespecified subgroup analyses by sex were reported in the STEP-1 publication; the interaction was not statistically significant and subgroup confidence intervals overlap.

Safety by sex

Overall safety was reported by sex subgroup, but precision is limited for rare events.

PK by sex

—

Missing data and generalizability limits

Detailed menopausal status and contraceptive use were not reported.

Exclusion of pregnancy and lactation limits applicability to those life stages.

Sources

Primary records

Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1)
peer reviewed article · New England Journal of Medicine · 2021-03-18
Phase 3 trial of semaglutide 2.4 mg for chronic weight management.

Medical reviewer

Medical Reviewer (Pending Assignment)

Medical review pending assignment by a licensed clinician.

Last reviewed 2026-08-01Next review 2026-11-01

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