A phase III, randomized, Open-Label, Active-Controlled study to evaluate the efficacy and safety of enicepatide versus tirzepatide among participants with type 2 diabetes and inadequate glycemic control on oral Glucose-Lowering medications

NCT ID NCT07889648

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 22, 2026 · Last updated Oct 22, 2026

Summary

The study will evaluate the efficacy and safety of enicepatide, a glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide receptor (GLP-1/GIP) receptor agonist (RA), compared with tirzepatide among participants with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on oral glucose-lowering medications.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 948 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have a diagnosis of type 2 diabetes mellitus (T2DM) based on World Health Organization (WHO) classification or other locally applicable diagnostic standards and have inadequate glycemic control in the opinion of the investigator * Have a HbA1c of ≥7.5% to ≤10.5% (or 58 millimole (mmol)/mol to 91 mmol/mol) at screening * Receiving stable T2DM treatment with oral glucose-lowering medication, during the 90 days prior to screening, and throughout the screening period until randomization; Dose of oral glucose-lowering medication is considered stable if the dose was unchanged during this 90-day period * Agree to not initiate a new diet, fast, and/or exercise program during the study which may result in changes in body weight or HbA1c, other than the standard of care lifestyle and dietary measures for diabetes treatment Exclusion Criteria: * History of type 1 diabetes mellitus (T1DM) diagnosis * History of ketoacidosis or hyperosmolar state/coma within 12 months prior to screening * One or more episodes of Level 3 hypoglycemia (per 2026 American Diabetes Association (ADA) Standards of Care in Diabetes) and/or one or more episodes of hypoglycemia unawareness within the 6 months prior to screening * Self-reported change in body weight of more than 5 kilogram (kg) gain or loss within 90 days prior to screening * Used any injectable glucose-lowering medication during the 90 days prior to screening, and throughout the screening period until randomization. Short term treatment with insulin for \<14 days is permitted for necessary clinical situations * Body Mass Index (BMI) \<25.0 kg/square meter (m2) at screening * Estimated glomerular filtration rate (eGFR) \<15 milliliters per minute per 1.73 square meters (mL/min/1.73 m2) * Treatment with any approved, investigational, compounded, or biosimilar versions of GLP-1 RA-based therapy (e.g., GLP-1 receptor agonist, GLP-1/GIP receptor agonist/antagonist, GLP-1/Glucagon receptor agonist, or GLP-1/GIP/Glucagon receptor agonist) or amylin analog within 6 months prior to randomization * Prior non-response or intolerance to contemporary GLP-1 RA-based therapies

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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  2. A doctor treating you

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