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Study · Randomized controlled trial · n = 1,032 · 2025

7 results

Tirzepatide for Obesity Treatment and Diabetes Prevention.

Jastreboff AM, le Roux CW, Stefanski A, Aronne LJ, Halpern B, Wharton S, Wilding JPH, Perreault L, Zhang S, Battula R, Bunck MC, Ahmad NN, Jouravskaya I

The New England journal of medicine13 Nov 2024Cited by 343 (Europe PMC)

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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and prediabetes, tirzepatide 5 mg reduced body weight more than placebo at 176 weeks.

    In plain wordsIn adults with obesity and prediabetes, 5 mg of tirzepatide led to more weight loss than placebo after 176 weeks.

    Outcome
    DecreasePercent change in body weight at week 176 (5 mg)
    Study

    n = 1,032

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    5 mg once weekly · 176 weeksAs given in this study (human).

    Measurements

    percent change in body weight
    −12.3%
    tirzepatide 5 mg
    percent change in body weight
    −1.3%
    placebo

    Source sentences

    Summary
    At 176 weeks, the mean percent change in body weight among the participants who received tirzepatide was -12.3% with the 5-mg dose, -18.7% with the 10-mg dose, and -19.7% with the 15-mg dose, as compared with -1.3% among those who received placebo (P<0.001 for all comparisons with placebo).
    2 context sentences
    Summary · context
    We performed a phase 3, double-blind, randomized, controlled trial in which 2539 participants with obesity, of whom 1032 also had prediabetes, were assigned in a 1:1:1:1 ratio to receive tirzepatide at a once-weekly dose of 5 mg, 10 mg, or 15 mg or placebo.
    Summary · context
    The current analysis involved the participants with both obesity and prediabetes, who received their assigned dose of tirzepatide or placebo for a total of 176 weeks, followed by a 17-week off-treatment period.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and prediabetes, tirzepatide 10 mg reduced body weight more than placebo at 176 weeks.

    In plain wordsIn adults with obesity and prediabetes, 10 mg of tirzepatide led to more weight loss than placebo after 176 weeks.

    Outcome
    DecreasePercent change in body weight at week 176 (10 mg)
    Study

    n = 1,032

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    10 mg once weekly · 176 weeksAs given in this study (human).

    Measurements

    percent change in body weight
    −18.7%
    tirzepatide 10 mg
    percent change in body weight
    −1.3%
    placebo

    Source sentences

    Summary
    At 176 weeks, the mean percent change in body weight among the participants who received tirzepatide was -12.3% with the 5-mg dose, -18.7% with the 10-mg dose, and -19.7% with the 15-mg dose, as compared with -1.3% among those who received placebo (P<0.001 for all comparisons with placebo).
    2 context sentences
    Summary · context
    We performed a phase 3, double-blind, randomized, controlled trial in which 2539 participants with obesity, of whom 1032 also had prediabetes, were assigned in a 1:1:1:1 ratio to receive tirzepatide at a once-weekly dose of 5 mg, 10 mg, or 15 mg or placebo.
    Summary · context
    The current analysis involved the participants with both obesity and prediabetes, who received their assigned dose of tirzepatide or placebo for a total of 176 weeks, followed by a 17-week off-treatment period.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and prediabetes, tirzepatide 15 mg reduced body weight more than placebo at 176 weeks.

    In plain wordsIn adults with obesity and prediabetes, 15 mg of tirzepatide led to more weight loss than placebo after 176 weeks.

    Outcome
    DecreasePercent change in body weight at week 176 (15 mg)
    Study

    n = 1,032

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    15 mg once weekly · 176 weeksAs given in this study (human).

    Measurements

    percent change in body weight
    −19.7%
    tirzepatide 15 mg
    percent change in body weight
    −1.3%
    placebo

    Source sentences

    Summary
    At 176 weeks, the mean percent change in body weight among the participants who received tirzepatide was -12.3% with the 5-mg dose, -18.7% with the 10-mg dose, and -19.7% with the 15-mg dose, as compared with -1.3% among those who received placebo (P<0.001 for all comparisons with placebo).
    2 context sentences
    Summary · context
    We performed a phase 3, double-blind, randomized, controlled trial in which 2539 participants with obesity, of whom 1032 also had prediabetes, were assigned in a 1:1:1:1 ratio to receive tirzepatide at a once-weekly dose of 5 mg, 10 mg, or 15 mg or placebo.
    Summary · context
    The current analysis involved the participants with both obesity and prediabetes, who received their assigned dose of tirzepatide or placebo for a total of 176 weeks, followed by a 17-week off-treatment period.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and prediabetes, fewer participants on tirzepatide than on placebo were diagnosed with type 2 diabetes over 176 weeks.

    In plain wordsIn adults with obesity and prediabetes, fewer people on tirzepatide than on placebo developed type 2 diabetes over 176 weeks.

    Outcome
    DecreaseOnset of type 2 diabetes during 176 weeks
    Study

    n = 1,032

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5, 10 or 15 mg once weekly · 176 weeksAs given in this study (human).

    Measurements

    type 2 diabetes diagnosis
    1.3%
    tirzepatide
    type 2 diabetes diagnosis
    13.3%
    placebo
    hazard ratio
    0.07 HR
    tirzepatide vs placebo

    Source sentences

    Summary
    Fewer participants received a diagnosis of type 2 diabetes in the tirzepatide groups than in the placebo group (1.3% vs. 13.3%; hazard ratio, 0.07; 95% confidence interval [CI], 0.0 to 0.1; P<0.001).
    2 context sentences
    Summary · context
    We performed a phase 3, double-blind, randomized, controlled trial in which 2539 participants with obesity, of whom 1032 also had prediabetes, were assigned in a 1:1:1:1 ratio to receive tirzepatide at a once-weekly dose of 5 mg, 10 mg, or 15 mg or placebo.
    Summary · context
    The current analysis involved the participants with both obesity and prediabetes, who received their assigned dose of tirzepatide or placebo for a total of 176 weeks, followed by a 17-week off-treatment period.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with obesity and prediabetes, after 17 weeks off treatment fewer participants who had received tirzepatide than placebo had type 2 diabetes.

    In plain wordsIn adults with obesity and prediabetes, after 17 weeks off treatment, fewer former tirzepatide users than former placebo users had type 2 diabetes.

    Outcome
    DecreaseType 2 diabetes after 17 weeks off treatment
    Study

    n = 1,032

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    5, 10 or 15 mg once weekly · 176 weeksAs given in this study (human).

    Measurements

    type 2 diabetes diagnosis
    2.4%
    tirzepatide
    type 2 diabetes diagnosis
    13.7%
    placebo
    hazard ratio
    0.12 HR
    tirzepatide vs placebo

    Source sentences

    Summary
    After 17 weeks off treatment or placebo, 2.4% of the participants who received tirzepatide and 13.7% of those who received placebo had type 2 diabetes (hazard ratio, 0.12; 95% CI, 0.1 to 0.2; P<0.001).
    2 context sentences
    Summary · context
    We performed a phase 3, double-blind, randomized, controlled trial in which 2539 participants with obesity, of whom 1032 also had prediabetes, were assigned in a 1:1:1:1 ratio to receive tirzepatide at a once-weekly dose of 5 mg, 10 mg, or 15 mg or placebo.
    Summary · context
    The current analysis involved the participants with both obesity and prediabetes, who received their assigned dose of tirzepatide or placebo for a total of 176 weeks, followed by a 17-week off-treatment period.
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with obesity and prediabetes, the most common adverse events with tirzepatide other than coronavirus disease 2019 were gastrointestinal, mostly mild to moderate and mainly during dose escalation in the first 20 weeks.

    In plain wordsIn adults with obesity and prediabetes, apart from coronavirus disease 2019, tirzepatide's most common side effects were stomach and gut problems.

    Outcome
    Direction not reportedMost common adverse events
    Study

    n = 1,032

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    5, 10 or 15 mg once weekly · 176 weeksAs given in this study (human).

    Source sentences

    Summary
    Other than coronavirus disease 2019, the most common adverse events were gastrointestinal, most of which were mild to moderate in severity and occurred primarily during the dose-escalation period in the first 20 weeks of the trial.
    2 context sentences
    Summary · context
    We performed a phase 3, double-blind, randomized, controlled trial in which 2539 participants with obesity, of whom 1032 also had prediabetes, were assigned in a 1:1:1:1 ratio to receive tirzepatide at a once-weekly dose of 5 mg, 10 mg, or 15 mg or placebo.
    Summary · context
    The current analysis involved the participants with both obesity and prediabetes, who received their assigned dose of tirzepatide or placebo for a total of 176 weeks, followed by a 17-week off-treatment period.
  7. 07HumanRandomized controlled trialSafety outcome

    In adults with obesity and prediabetes, three years of tirzepatide treatment produced no new safety signals.

    In plain wordsIn adults with obesity and prediabetes, three years of tirzepatide treatment showed no new safety signals.

    Outcome
    No significant changeNew safety signals
    Study

    n = 1,032

    Outcome group
    Adverse events · Whole body
    Studied dose
    5, 10 or 15 mg once weekly · 176 weeksAs given in this study (human).

    Source sentences

    Summary
    No new safety signals were identified.
    2 context sentences
    Summary · context
    We performed a phase 3, double-blind, randomized, controlled trial in which 2539 participants with obesity, of whom 1032 also had prediabetes, were assigned in a 1:1:1:1 ratio to receive tirzepatide at a once-weekly dose of 5 mg, 10 mg, or 15 mg or placebo.
    Summary · context
    The current analysis involved the participants with both obesity and prediabetes, who received their assigned dose of tirzepatide or placebo for a total of 176 weeks, followed by a 17-week off-treatment period.

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

Registered trials4

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

4 trials · 3 not yet recruiting · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Not yet recruitingPhase 2/3NCT07734792

Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial

yifang zhun = 726est. 20 Sept 2026 to est. 31 Jul 2028

Acute Ischemic Stroke (AIS)

Not yet recruitingPhase 4NCT07756359

Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)

University of North Carolina, Chapel Hilln = 20est. Sept 2026 to est. Sept 2027

Pouch, Ileal · Pouches, Ileoanal · Bowel Diseases, Inflammatory

Trial pageClinicalTrials.govUpdated 10 Aug 2026
Not yet recruitingPhase not statedNCT07504172

Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity

Radboud University Medical Centern = 1,700est. 1 Apr 2026 to est. 1 Aug 2026

Overweight , Obesity · Obesity (Disorder)

Trial pageClinicalTrials.govUpdated 31 Mar 2026
CompletedPhase 3Results postedNCT04184622

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

Eli Lilly and Companyn = 2,5394 Dec 2019 to 6 Jul 2024

Overweight · Obesity

Trial pageClinicalTrials.govUpdated 24 Jul 2025

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.

  1. Version 2Current

    9 Oct 2026, 19:08 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:07 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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