Drug

Tirzepatide

Research on tirzepatide, a dual GIP/GLP-1 receptor agonist, including SURPASS, SURMOUNT, and cardiovascular-focused substudies.

Sources: FDA label · 6 registered trials · 5 key papers

Where experts stand

Latest: SUMMIT Remodeling

AHA Scientific Sessions 2026

1 expert has reacted so far. We show the split once 3 have.

“This really is a practice-changing trial and cements this type of therapy as one of the cornerstones of obesity and HFpEF treatment.”
Jennifer Ho, Associate Professor of Medicine, Harvard Medical School · News Coverage ·

Expert labels are toward SUMMIT Remodeling's result, from named public quotes (n=1). As of Nov 3, 2026.

Tirzepatide at a glance

GLP-1 Receptor Agonists

Mechanism: glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist · FDA label (DailyMed)

Boxed warning:Risk of thyroid C-cell tumors

FDA-approved indications (Mounjaro)

As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
To reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.
To reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.

FDA-approved indications (Zepbound)

In combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
In combination with a reduced-calorie diet and increased physical activity to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

Source: Zepbound label (DailyMed), label dated Aug 28, 2026

Landmark trials

Primary results of 2 trials behind the evidence on tirzepatide, as each trial’s own publication reports them.

Left of the line at 1 favours the intervention; square size tracks trial size.Favours the interventionNo significant differenceFavours the comparator

0.250.512

SUMMITprimary end point 1: CV death or worsening HF
tirzepatide vs placebo · 731 patients · N Engl J Med 2025
In patients with heart failure with preserved ejection fraction and obesity
Primary outcome: a composite of adjudicated death from cardiovascular causes or a worsening heart-failure event (assessed in a time-to-first-event analysis)
HR 0.62 (0.41–0.95)
SURPASS-CVOT
tirzepatide vs dulaglutide · 13,299 patients · N Engl J Med 2025
In patients with type 2 diabetes and atherosclerotic cardiovascular disease
Primary outcome: a composite of death from cardiovascular causes, myocardial infarction, or stroke
HR 0.92 (0.83–1.01, 95.3% CI)

Reported as a difference or win ratio

SUMMITprimary end point 2: KCCQ-CSS change at 52 weeks
tirzepatide vs placebo · 731 patients · N Engl J Med 2025
Primary outcome: the change from baseline to 52 weeks in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS
“between-group difference, 6.9; 95% CI, 3.3 to 10.6; P<0.001”

Results are quoted from each trial’s primary publication abstract (PubMed); the trial name links to the paper. Ratios below 1 favour the intervention. Confidence intervals are 95% unless marked.

Trials by indication

Registered trials with tirzepatide in an arm, past phase 1 with at least 50 participants: the largest in each indication, newest first. Trials that give it only as the comparator are tagged; trials that give it in every arm are listed last.

Type 2 diabetes

SURPASS-CVOT
The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)
NCT04255433 · Phase 3 · Completed · 13,299 participants · started 2020

Obesity

SURMOUNT-1
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
NCT04184622 · Phase 3 · Completed · 2,539 participants · started 2019

Atrial fibrillation

Effect of Tirzepatide on Recurrence of Atrial Fibrillation After Catheter Ablation in Obese Patients: A Multicenter, Randomized, Open-Label Trial
NCT07715929 · Phase 4 · Not yet recruiting · 710 participants · started 2026

Stroke

Effect of Tirzepatide on Functional Outcomes in Patients With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy: A Multicenter, Randomized, Controlled, Blinded Outcome Assessment Trial
NCT07734792 · Phase 2/3 · Not yet recruiting · 430 participants · started 2026

Heart failure

Identifying Therapeutic Mechanisms for Incretin-Based Treatment in Obesity-Related Heart Failure With Preserved Ejection Fraction (HFpEF)
NCT07554638 · Phase 4 · Recruiting · 50 participants · started 2026

Source: ClinicalTrials.gov registry records.

Safety and label changes

Boxed warning

Risk of thyroid C-cell tumors

Full text: FDA label (DailyMed), label dated Aug 27, 2026

Label updates and FDA notices

Apr 30, 2026FDA announcement: FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
Nov 1, 2024FDA label update: Mounjaro (Tirzepatide)
Oct 18, 2024FDA label update: Zepbound (Tirzepatide)

Source: FDA (Drugs@FDA and FDA announcements).

How this page is built

A clinical question appears here only when its condition matches this topic, an outcome and a comparator were extracted from the studies, at least two studies and a patient count are on file, and the certainty is low or higher.

Supports benefit, no benefit shown, and mixed describe the direction of the measured effect. No benefit shown means the evidence does not support a benefit. It is not a finding of harm. Too little evidence means the question did not clear that bar.

Study count, RCT count, and patient count are separate. The patient total adds only studies that are linked into a study family and whose sample size is not flagged as implausible. A reversal is listed only when at least one randomized trial sits on each side of the change.

The overview is drafted from the guideline recommendations, trials, papers, and questions on this page, and every sentence has to cite one of them. It stays unverified until an NPI-verified clinician or a Synapse admin approves it. Approving records that person's name.

Tirzepatide

Latest: SUMMIT Remodeling

Tirzepatide at a glance

Overview

Definition

Landmark trials

Reported as a difference or win ratio

Trials by indication

Safety and label changes

Other GLP-1 Receptor Agonists

Key papers

New research on Tirzepatide

How this page is built

Leading authors