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Human controlled primaryStrong for continuation-versus-withdrawal comparisonCompleted; peer reviewed

SURMOUNT-4 continuation-versus-withdrawal trial

TIRZEPATIDE-STUDY-P061

Aronne et al. (2024), SURMOUNT-4.

Study design

Record details

Design: Open-label lead-in followed by randomized withdrawal.
Population or model: Adults with obesity or overweight who completed the protocol-defined lead-in.
Material tested: Lilly-manufactured tirzepatide clinical product.
Comparator: Continued tirzepatide versus placebo after the lead-in.

Evidence record

Endpoints

Body-weight change during continued treatment versus randomized withdrawal.

Qualified findings

SURMOUNT-4 addresses continuation versus withdrawal after a lead-in.

Limitations

Randomization occurred only after the open-label lead-in; durability after discontinuation remains bounded.

Reports and sources

P061Human controlled primary (36-wk open-label lead-in then randomised withdrawal); PEER REVIEWED; RESULTS POSTED

Aronne et al. 2024 SURMOUNT-4

(2024). DOI: 10.1001/jama.2023.24945