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
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 948 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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