NCT07889648Not yet recruitingPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 948 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 2 Apr 2029
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Type 2 diabetes
- NCT number
- NCT07889648
- EU CT number
- 2026-526948-13-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 948
- From 1 Dec 2026 to the primary completion date, 2 Apr 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- History of type 1 diabetes mellitus (T1DM) diagnosis
Lab values
- 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
- Estimated glomerular filtration rate (eGFR) \<15 milliliters per minute per 1.73 square meters (mL/min/1.73 m2)
Other
- Body Mass Index (BMI) \<25.0 kg/square meter (m2) at screening
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.