Trial profile

Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1)

ClinicalTrials.gov: NCT04184622

Design and population

Sponsor

Eli Lilly and Company

Phase

Phase 3

Design

Randomized, double-blind, placebo-controlled, parallel-group trial

Overall status

Completed; results published

Enrollment

Planned enrollment

—

Actual enrollment

—

Population summary

2,539 adults with obesity or overweight without diabetes and with at least one weight-related comorbidity.

Sex eligibility

—

Reproductive and life-stage eligibility

Pregnancy eligibility

—

Lactation eligibility

—

Reproductive-potential requirements

—

Sex-stratification / analysis plan

—

Medicines studied

Tirzepatide

Dual GIP/GLP-1 receptor agonist

What can and cannot be concluded for women

Conclusions depend on whether women were enrolled in sufficient numbers, whether a sex analysis was prespecified and powered, and what life-stage data were reported. Use the enrollment and analysis details above to judge how far the results can be generalized, and verify the current trial status at ClinicalTrials.gov.

Sources

Primary records

Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1)
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).
FDA Statistical Review — NDA 217806 (Zepbound)
regulatory review
FDA statistical review including subgroup analyses by sex for SURMOUNT-1 and SURMOUNT-2.

Direct registry link: verify status and results at ClinicalTrials.gov.

Medical disclaimer: Her Health Peptides publishes educational, source-linked summaries. We do not provide individualized medical advice, diagnosis, or treatment recommendations. Always talk with a licensed clinician about your specific situation, especially if you are pregnant, breastfeeding, planning pregnancy, or taking other medicines.