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 Participants withdrawn to placebo regained 14.0% Primary source linked: the source is a citable peer-reviewed / registry record, which we have not independently re-extracted from the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
| Design | Phase 3 randomised withdrawal trial |
|---|---|
| Population | Adults with obesity who completed an open-label tirzepatide lead-in |
| Sample size | 670 randomised |
| Intervention | Not stated (Maximum tolerated) |
| Comparator | Placebo, after withdrawal |
| Duration | 88 weeks total, 36-week open-label lead-in then 52-week randomised withdrawal |
| Primary endpoint | Percentage change in body weight during the randomised withdrawal period |
| Sponsor | Eli Lilly and Company |
Results
Participants who continued lost a further 5.5%. Participants withdrawn to placebo regained 14.0%
| Arm | Reported change |
|---|---|
| Continued tirzepatide, further loss | 5.5% |
| Withdrawn to placebo, regain | 14% |
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
- Aronne LJ et al., JAMA 2024. NCT04660643 — Peer-reviewed publication
- 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/