Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial
- Design
- Randomized trial · 670 participants · Intermediate outcome
- Match to healthy normal-weight adults aged 55–75
- Different populationObesity without diabetes; younger.
- Could weight loss explain it?
- Not applicable[Auto] Participants had obesity and/or type 2 diabetes and the abstract does not separate direct drug effects from weight loss or glycaemic improvement.
- Study tier
- Study tier 1[Auto] Randomized trial of moderate size; outcome type and follow-up limit certainty (auto-provisional).
- Assessment
- Version 2 · curated · Sep 13, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
People who switched from tirzepatide to placebo after 36 weeks regained about 14% of body weight within a year, while those continuing lost a further 5.5%. Stopping reverses the effect.
01Findings
What the study reported
- Drugs
- Tirzepatide
- Dose
- 10 or 15 mg weekly
- Route
- subcutaneous
- Treatment duration
- 36-week lead-in then 52-week randomized withdrawal
- Comparator
- placebo
- Primary outcome
- Percent weight change from week 36 to 88
- Effect
- -5.5% (continued) vs +14.0% (placebo); difference -19.4%
- 95% confidence interval
- -21.2 to -17.7
- P value
- <0.001
- Follow-up
- 88 weeks
- Adverse events
- Not extracted
- Limitations
- Auto-classified from abstract only; effect estimates, adverse events and limitations not extracted. Requires manual review.
Who was studied
- Mean age
- 48
- Sex distribution
- 71% female
- Obesity status
- obesity or overweight with complication
- Diabetes status
- excluded
- Sample size
- 670
Study quality details
- Study design
- Randomized controlled trial
- Sample size
- 670
- Randomization
- yes
- Blinding
- double-blind
- Comparator
- placebo
- Follow up duration
- 36 weeks
- Outcome type
- unknown
- Replication
- not assessed (auto)
- Consistency with other evidence
- not assessed (auto)
- Population applicability
- INDIRECT
- Statistical precision
- CI reported: 95% CI, -21
- Risk of bias
- not assessed (auto)
- Funding conflicts
- no
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- Eli Lilly
- Industry funded
- Yes
- Manufacturer
- Eli Lilly
- Sponsor role
- Sponsor designed and analysed.
- Author conflicts
- Authors report Eli Lilly relationships; sponsor co-authors.
- Independent replication
- consistent with STEP 1 extension
Funding is shown on every study and never used to score it.
03Claims
Claims this study bears on
- Stopping GLP-1 therapy leads to regain of most lost weight and reversal of cardiometabolic improvements.Supports
SURMOUNT-4 randomized withdrawal.
04Source
The source, as retrieved
Abstract
[IMPORTANCE] The effect of continued treatment with tirzepatide on maintaining initial weight reduction is unknown. [OBJECTIVE] To assess the effect of tirzepatide, with diet and physical activity, on the maintenance of weight reduction. [DESIGN, SETTING, AND PARTICIPANTS] This phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries with a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period included adults with a body mass index greater than or equal to 30 or greater than or equal to 27 and a weight-related complication, excluding diabetes. [INTERVENTIONS] Participants (n = 783) enrolled in an open-label lead-in period received once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks. [MAIN OUTCOMES AND MEASURES] The primary end point was the mean percent change in weight from week 36 (randomization) to week 88. Key secondary end points included the proportion of participants at week 88 who maintained at least 80% of the weight loss during the lead-in period. [RESULTS] Participants (n = 670; mean age, 48 years; 473 [71%] women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. The mean percent weight change from week 36 to week 88 was -5.5% with tirzepatide vs 14.0% with placebo (difference, -19.4% [95% CI, -21.2% to -17.7%]; P < .001). Overall, 300 participants (89.5%) receiving tirzepatide at 88 weeks maintained at least 80% of the weight loss during the lead-in period compared with 16.6% receiving placebo (P < .001). The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo. The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo. [CONCLUSIONS AND RELEVANCE] In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction. [TRIAL REGISTRATION] ClinicalTrials.gov Identifier: NCT04660643.
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Sep 13, 2026 | 38078870 first ingestion |