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ENI-SPIRE-2

Not 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

Lead sponsor

Hoffmann-La Roche

Assets

CT-388 / Tirzepatide

Listed sites

0

Recruiting sites

-

Estimated enrollment

948

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 7.5-10.5%

Primary endpoint

•Glycosylated Hemoglobin (HbA1c, %)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07889648
Org study IDWC45975
Secondary ID2026-526948-13-00

Timeline

Milestones

Study first posted2026-10-22actual
Last update posted2026-10-22actual
Study start2026-12-01estimated
Primary completion2029-04-02estimated
Study completion2029-04-23estimated

Assets

Investigational agents

CT-388Tirzepatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (25)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
9
Weight & body composition
7
Cardiometabolic biomarkers
7
Renal / kidney
1
Safety / tolerability / PK
1

Weight & body composition

7 endpoints
Secondary/protocol endpoint

Percent Change From Baseline to Week 72 in Body Weight

Time frame:Baseline through Week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Weight Loss of ≥5% at Week 72

Time frame:At Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Weight Loss of ≥10% at Week 72

Time frame:At Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Weight Loss of ≥15% at Week 72

Time frame:At Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline to Week 72 in Waist Circumference

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 72 in Waist-to-Height Ratio

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c of ≤6.5% and Weight Loss of ≥10% at Week 72

Time frame:At Week 72

threshold achievement, improvement

Glycemic / diabetes

9 endpoints
Primary/protocol endpoint

Change From Baseline to Week 72 in Glycosylated Hemoglobin (HbA1c, %)

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c of ≤6.5% at Week 72

Time frame:At Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c of <5.7% at Week 72

Time frame:At Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline to Week 72 in Fasting Glucose

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c of <7% at Week 72

Time frame:At Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline to Week 72 in 7-Point Self-Monitoring Blood Glucose (SMBG) Profiles

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c of <7% at Week 72 Without Clinically Significant, Documented Symptomatic Hypoglycemia, or Severe Hypoglycemia

Time frame:At Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c of <6.5% at Week 72 Without Clinically Significant, Documented Symptomatic Hypoglycemia, or Severe Hypoglycemia

Time frame:At Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c of <5.7% at Week 72 Without Clinically Significant, Documented Symptomatic Hypoglycemia, or Severe Hypoglycemia

Time frame:At Week 72

threshold achievement, improvement

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Change From Baseline to Week 72 in Urine Albumin to Creatinine Ratio (UACR)

Time frame:Baseline through Week 72

change from baseline, improvement

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Change From Baseline to Week 72 in Total Cholesterol

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 72 in Triglycerides

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 72 in Low-Density Lipoprotein Cholesterol (LDL-C)

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 72 in High-Density Lipoprotein Cholesterol (HDL-C)

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 72 in Systolic Blood Pressure

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 72 in Diastolic Blood Pressure

Time frame:Baseline through Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 72 in High-Sensitivity C-Reactive Protein (hsCRP)

Time frame:Baseline through Week 72

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence and Severity of Adverse Events

Time frame:From Baseline up to Week 75

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.