“Were Women Studied?” audit
SURMOUNT-1 (NCT04184622) and the broader SURMOUNT program
Women were enrolled in large numbers in the tirzepatide obesity development program, but interpretable sex-specific analyses and life-stage denominators remain limited.
Representation grade
Target population represented
Sex-analysis grade
Post hoc / exploratory
Target population represented with useful denominator detail
Basis: SURMOUNT-1 enrolled 2,539 participants and roughly 67.5% were female, reflecting the higher enrollment of women commonly seen in obesity trials.
Post hoc/exploratory subgroup analysis
Population and enrollment
Enrollment breakdown
Terminology in source: Published trial reports and FDA reviews describe 'sex' (female/male).
0.0%
women / female participants
0 of 0 enrolled
Inclusion and exclusion by life stage
Sex-analysis plan and findings
Missing data and generalizability limits
Menopausal status, contraceptive use, and menstrual-cycle phase are not consistently reported.
Pregnancy, lactation, and significant renal/hepatic disease were exclusion criteria; findings may not generalize to those groups.
Sources
Primary records
- peer reviewed article · New England Journal of Medicine · 2022-07-21
Phase 3 trial of tirzepatide in adults with obesity or overweight without diabetes (NCT04184622).
- regulatory review
FDA statistical review including subgroup analyses by sex for SURMOUNT-1 and SURMOUNT-2.
- peer reviewed article · Eli Lilly / EASD 2024 · 2024
Industry-reported subgroup analysis of tirzepatide efficacy by sex across SURMOUNT trials.
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