Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial.

Aronne LJ, Sattar N, Horn DB, Bays HE, Wharton S, Lin WY, Ahmad NN, Zhang S, Liao R, Bunck MC, Jouravskaya I, Murphy MA

JAMA1 Jan 2024Cited by 689 (Europe PMC)

PMID38078870PMCIDPMC10714284DOI10.1001/jama.2023.24945PepBankPUB-38078870

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with obesity or overweight who lost weight on tirzepatide, continuing tirzepatide gave a mean weight change of -5.5% versus 14.0% after switching to placebo, from week 36 to 88.
In plain wordsIn adults with obesity or overweight, people who kept taking tirzepatide kept their weight loss, while those switched to placebo regained weight.
Peptide
Tirzepatide
Outcome
DecreasePercent weight change from week 36 to week 88
Study
n = 670
Comparator
Placebo (switched at week 36)
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
maximum tolerated dose (10 or 15 mg) · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Mean weight change
−5.5%
tirzepatide
Mean weight change
14%
placebo
Difference
−19.4%
tirzepatide vs placebo
Source sentences
Summary
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).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary end point was the mean percent change in weight from week 36 (randomization) to week 88.
Summary · context
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…
Summary · context
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.
Report a problemFND-3807887001
02HumanRandomized controlled trialEfficacy outcome
In adults with obesity or overweight, more participants kept at least 80% of their lead-in weight loss at week 88 with continued tirzepatide than with placebo.
In plain wordsIn adults with obesity or overweight, far more people kept most of their weight loss at week 88 on tirzepatide than on placebo.
Peptide
Tirzepatide
Outcome
IncreaseMaintained at least 80% of lead-in weight loss at week 88
Study
n = 670
Comparator
Placebo (switched at week 36)
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
maximum tolerated dose (10 or 15 mg) · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Proportion maintaining >=80% of weight loss
89.5%
tirzepatide
Proportion maintaining >=80% of weight loss
16.6%
placebo
Source sentences
Summary
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).
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
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…
Summary · context
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.
Report a problemFND-3807887002
03HumanRandomized controlled trialEfficacy outcome
In adults with obesity or overweight who completed the open-label lead-in, tirzepatide gave a mean weight reduction of 20.9%.
In plain wordsIn adults with obesity or overweight, people who completed 36 weeks of tirzepatide lost 20.9% of their weight on average.
Peptide
Tirzepatide
Outcome
DecreaseWeight reduction during 36-week lead-in
Study
n = 670
Outcome group
Body weight · Metabolic and weight
Studied dose
maximum tolerated dose (10 or 15 mg) · subcutaneous · 36 weeksAs given in this study (human).
Measurements
Mean weight reduction
20.9%
lead-in, week 0 to 36
Source sentences
Summary
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%.
2 context sentences(design, population, supporting numbers)
Summary · context
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…
Summary · context
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.
Report a problemFND-3807887003
04HumanRandomized controlled trialEfficacy outcome
In adults with obesity or overweight, overall weight reduction from week 0 to 88 was 25.3% with continued tirzepatide and 9.9% with switch to placebo.
In plain wordsIn adults with obesity or overweight, total weight loss at week 88 was 25.3% on continued tirzepatide and 9.9% after switching to placebo.
Peptide
Tirzepatide
Outcome
DecreaseOverall weight reduction from week 0 to week 88
Study
n = 670
Comparator
Placebo (switched at week 36)
Outcome group
Body weight · Metabolic and weight
Studied dose
maximum tolerated dose (10 or 15 mg) · subcutaneous · 88 weeksAs given in this study (human).
Measurements
Mean weight reduction
25.3%
tirzepatide
Mean weight reduction
9.9%
placebo
Source sentences
Summary
The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
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…
Summary · context
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.
Report a problemFND-3807887004
05HumanRandomized controlled trialSafety outcome
In adults with obesity or overweight, the most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more often with tirzepatide than placebo.
In plain wordsIn adults with obesity or overweight, stomach and gut side effects were most common, mostly mild or moderate, and more frequent with tirzepatide than placebo.
Peptide
Tirzepatide
Outcome
IncreaseGastrointestinal adverse events
Study
n = 670
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
maximum tolerated dose (10 or 15 mg) · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
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…
Summary · context
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.
Report a problemFND-3807887005

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT04660643

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss

Eli Lilly and Companyn = 78329 Mar 2021 to 18 May 2023

Obesity · Overweight

Trial page ClinicalTrials.govUpdated 22 May 2024

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
9 Oct 2026, 19:08 UTC
Study results updated
Version 1
9 Oct 2026, 03:07 UTC
First added · source update from Europe PMC

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