What Is Tirzepatide? Research Evidence & FDA Status

Name: NOVABIO Tirzepatide reviewed research dataset
Creator: NOVABIO
License: https://novabiohealthy.com/pages/terms-of-service

What Is Tirzepatide?

Tirzepatide (LY3298176) is a synthetic dual incretin receptor agonist. Its research record is organized here by molecular identity, GIP and GLP-1 receptors, registry data, published evidence and current FDA context. NOVABIO product and COA records are presented separately from clinical evidence. FDA-approved tirzepatide drug products exist; NOVABIO catalogue material is not an FDA-approved drug.

Evidence boundary

Clinical evidence, product identity and batch documentation are separate records. This page does not provide dosing, administration or treatment recommendations.

Evidence at a Glance

315ClinicalTrials.gov records

2595PubMed query records

6Selected publications

0Exact product COA records

Human randomized trials

Type 2 diabetes

The SURPASS program includes randomized Phase 3 records and peer-reviewed outcomes in defined participant groups.

Human randomized trials

Obesity and overweight

The SURMOUNT program reports body-weight endpoints under specific protocols; those results do not describe NOVABIO material.

Condition-specific trials

Cardiometabolic conditions

Registry and publication records include sleep-apnea and heart-failure populations with protocol-specific endpoints.

Counts are synchronized search records, not a quality score or proof of efficacy.

Sources: PubMed search results · ClinicalTrials.gov records · Retrieved 2026-10-06

Mechanism & Pharmacology

Tirzepatide is described in the reviewed literature as synthetic dual incretin receptor agonist associated with GIP and GLP-1 receptors. Mechanistic descriptions identify the research question; they do not establish efficacy for an individual or a catalogue product.

Source: PubMed search results · Retrieved 2026-10-06

Clinical Development

6 decision-relevant records are shown on desktop and up to three on mobile. Use the official registry link below to review all 315 synchronized search records.

NCT ID / Study	Phase	Status	Context	Sponsor	Last registry update
NCT03954834A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone	Phase 3	Completed	Type 2 Diabetes Mellitus	Eli Lilly and Company	2021-10-20
NCT06803888Bariatric Surgery vs. Semaglutide vs. Tirzepatide	Phase 4	Active Not Recruiting	Obesity and Obesity-related Medical Conditions	Ali Aminian	2026-09-03
NCT05412004Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea	Phase 3	Completed	Obstructive Sleep Apnea, Obesity	Eli Lilly and Company	2025-04-30
NCT07738276Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity	Phase 3	Not Yet Recruiting	Heart Failure and Reduced Ejection Fraction, Obesity & Overweight, Tirzepatide	Shahid Beheshti University of Medical Sciences	2026-08-03
NCT07096063Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk	Not stated	Completed	Type 2 Diabetes, Overweight, Cardiovascular (CV) Risk	Brigham and Women's Hospital	2025-10-15
NCT06075667A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities	Phase 3	Active Not Recruiting	Obesity, Overweight	Eli Lilly and Company	2026-06-29

Source: ClinicalTrials.gov records · Retrieved 2026-10-06

Published Study OutcomesEvidence-level interpretation

Published Study Outcomes

SURPASS-1

A randomized Phase 3 publication evaluated tirzepatide in adults with type 2 diabetes inadequately controlled by diet and exercise.

SURMOUNT-1

A randomized Phase 3 publication evaluated tirzepatide in adults with obesity or overweight under the study's inclusion criteria.

SURMOUNT-OSA

Two randomized Phase 3 trials evaluated obstructive-sleep-apnea endpoints in adults with obesity; interpretation remains population and protocol specific.

Source: PubMed search results · Retrieved 2026-10-06

Identity & ChemistryForm-specific database fields

Identity & Chemistry

PubChem record: CID 156588324 · Tirzepatide
Molecular formula: C225H348N48O68
Molecular weight: 4813 g/mol
InChIKey: AAPYRSPHYSKGIS-MCNPHUAVSA-N

These fields apply to the cited PubChem record. Salt, counter-ion, hydration state and formulation must be confirmed from the actual product or batch record.

Source: PubChem CID 156588324 · Retrieved 2026-10-06

Research Tools for Tirzepatide

Review the selected records above or open the official registry for the complete result set.

Open all ClinicalTrials.gov records

Use the complete NOVABIO documentation library to review currently available batch records.

Open Lab Results & COA

Storage & Laboratory HandlingDocumentation-led controls

Storage & Laboratory Handling

Confirm the exact material form, lot, supplied state and storage statement from the product label and corresponding batch documentation. Do not infer handling conditions from a different compound, strength or external clinical publication.

Regulatory Status

FDA has approved tirzepatide drug products for specific indications. NOVABIO's catalogue material is a research product and is not an FDA-approved drug.

Source: FDA official information · Retrieved 2026-10-06

Research TimelineSelected milestones

Research Timeline

2018
Early clinical development records for LY3298176 were registered.
2021
SURPASS Phase 3 results were published.
2022
FDA approved Mounjaro for a specific type 2 diabetes indication.
2023
FDA approved Zepbound for chronic weight management in specified adults.
2026
Registry and PubMed records were resynchronized for this profile.

Selected Literature6 reviewed records

Selected Literature

Reviewed publication

Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial.

Lancet (London, England) · 2021 Jul 10

PMID 34186022

Reviewed publication

Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.

The New England journal of medicine · 2021 Aug 5

PMID 34170647

Reviewed publication

Tirzepatide Once Weekly for the Treatment of Obesity.

The New England journal of medicine · 2022 Jul 21

PMID 35658024

Reviewed publication

Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.

The New England journal of medicine · 2024 Oct 3

PMID 38912654

Reviewed publication

Tirzepatide as Compared with Semaglutide for the Treatment of Obesity.

The New England journal of medicine · 2025 Jul 3

PMID 40353578

Reviewed publication

Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity.

The New England journal of medicine · 2025 Jan 30

PMID 39555826

Source: PubMed search results · Retrieved 2026-10-06

Authoritative Data Summary

Tirzepatide Research Summary

Identity

Tirzepatide is identified in this profile as synthetic dual incretin receptor agonist; identity fields are tied to PubChem CID 156588324 and must be interpreted for that recorded form.

Mechanism

the reviewed literature describes GIP and GLP-1 receptors. A mechanism statement does not establish that a catalogue product produces a clinical effect.

Evidence

the synchronized searches returned 315 ClinicalTrials.gov records and 2595 PubMed records. Registry counts include records of different designs and statuses, while publication counts include multiple evidence types; neither count is a quality score. Evidence must be separated by level: a registry entry describes a protocol, a publication reports a defined analysis, and a preclinical experiment does not establish a human outcome. Dates, recruitment status and regulatory information can change, which is why this profile shows a verification date and links to current official search pages.

Regulatory context

FDA has approved tirzepatide drug products for specific indications. NOVABIO's catalogue material is a research product and is not an FDA-approved drug. Clinical findings apply only to the studied drug product, formulation, population and protocol. NOVABIO product specifications and batch documentation are separate catalogue records and do not inherit clinical outcomes from external studies. This profile therefore supports source tracing and compound comparison, but it does not certify a batch, recommend treatment, provide dosing instructions or replace current FDA labeling and professional medical judgment.

Sources: PubMed · ClinicalTrials.gov · PubChem · FDA

FAQ4 evidence-bounded answers

Tirzepatide FAQ

What is tirzepatide?

Tirzepatide, also called LY3298176, is a synthetic peptide that acts at GIP and GLP-1 receptors.

Is tirzepatide FDA approved?

FDA-approved tirzepatide drug products exist for specific indications. This does not make a research catalogue material an approved drug.

What receptors does tirzepatide target?

Peer-reviewed and FDA sources describe activity at GIP and GLP-1 receptors.

Does this page provide dosing guidance?

No. This profile summarizes identity, evidence, registry, chemistry and documentation records and does not provide dosing or treatment instructions.

Complete ReferencesReviewed identifiers; links consolidated by module

Complete References

NCT03954834 — A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
NCT06803888 — Bariatric Surgery vs. Semaglutide vs. Tirzepatide
NCT05412004 — Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
NCT07738276 — Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity
NCT07096063 — Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk
NCT06075667 — A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
PMID 34186022 — Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial.
PMID 34170647 — Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.
PMID 35658024 — Tirzepatide Once Weekly for the Treatment of Obesity.
PMID 38912654 — Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.
PMID 40353578 — Tirzepatide as Compared with Semaglutide for the Treatment of Obesity.
PMID 39555826 — Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity.
PubChem CID 156588324 — Tirzepatide
FDA regulatory source listed in the Regulatory Status module.

Sources, Methodology & Last Verified

Official sources: ClinicalTrials.gov, NCBI PubMed, PubChem, FDA, and NOVABIO product and COA records.
Inclusion: Exact Tirzepatide or LY3298176 identity and traceable registry, publication, chemistry, regulatory or batch fields.
Exclusion: News, supplier blogs, community posts, duplicate records and claims not tied to a reviewed source.
Last verified: October 6, 2026
Prepared by: NOVABIO Research
Corrections: Contact NOVABIO with the page URL and source record.