Clinical research

SURMOUNT-4: Continued tirzepatide versus withdrawal for weight maintenance

Phase 3 randomised withdrawal trial. 670 randomised, over 88 weeks total, 36-week open-label lead-in then 52-week randomised withdrawal. Sponsor: Eli Lilly and Company.

SURMOUNT-4 (NCT04660643) tested at Maximum tolerated against placebo, after withdrawal in adults with obesity who completed an open-label tirzepatide lead-in.Participants who continued lost a further 5.5%. Participants withdrawn to placebo regained 14.0% Primary source linked: the source is a citable peer-reviewed / registry record, which we have not independently re-extracted from the full paper in this session.

Study design

DesignPhase 3 randomised withdrawal trial
PopulationAdults with obesity who completed an open-label tirzepatide lead-in
Sample size670 randomised
InterventionNot stated (Maximum tolerated)
ComparatorPlacebo, after withdrawal
Duration88 weeks total, 36-week open-label lead-in then 52-week randomised withdrawal
Primary endpointPercentage change in body weight during the randomised withdrawal period
SponsorEli Lilly and Company

Results

Participants who continued lost a further 5.5%. Participants withdrawn to placebo regained 14.0%

Reported change by arm (chart data rendered as a table for accessibility)
ArmReported change
Continued tirzepatide, further loss5.5%
Withdrawn to placebo, regain14%

Adverse events & discontinuations

Not extracted from the source in this session.

Limitations

The lead-in selects for people who tolerated and responded to the drug, so both arms are a responder population. Says nothing about tapering strategies, which were not tested.

Practical interpretation

This is one trial, reported by Eli Lilly and Company, read directly against the registry and publication linked below — GLP Ranked has not re-run the statistics or obtained the patient-level data. Results describe group averages under trial conditions and may not describe any individual's outcome, including with a compounded, non-FDA-approved version of a similar active ingredient. Always check the primary source before citing a specific number.

Sources

  1. Aronne LJ et al., JAMA 2024. NCT04660643 — Peer-reviewed publication
  2. SURMOUNT-4 — ClinicalTrials.gov record NCT04660643 — Trial registry record

Cite this page

GLP Ranked. "SURMOUNT-4: Continued tirzepatide versus withdrawal for weight maintenance." Updated 2026-07-24. https://glpranked.com/research/surmount-4/

GLP Ranked. "SURMOUNT-4: Continued tirzepatide versus withdrawal for weight maintenance." Updated 2026-07-24. https://glpranked.com/research/surmount-4/