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- ENI-SPIRE-2
A Clinical Study to Evaluate the Effects of Enicepatide Versus Tirzepatide in Participants With Type 2 Diabetes and Inadequate Blood Sugar Control on Oral Glucose-Lowering Medications
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Metabolic Disorder -
Type 2 Diabetes Mellitus
- For Medical Professional
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Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Study Identifier
NCT07889648, WC45975, 2026-526948-13-00
Condition
Type 2 Diabetes Mellitus
Official Title
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
Study 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.
Eligibility Criteria
All
≥18 Years
No
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com