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Not yet recruitingNCT07889648ENI-SPIRE-2Updated Oct 22, 2026

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 3 interventional study of Enicepatide and Tirzepatide in Type 2 Diabetes Mellitus, sponsored by Hoffmann-La Roche. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
948
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's planned enrollment of 948 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.

Browse Hoffmann-La Roche studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
948 participants (estimated)

Study arms

  • Active comparator
    Arm 1: Tirzepatide

    Participants will receive tirzepatide.

    Combination Product: Tirzepatide

  • Experimental
    Arm 2: Enicepatide

    Participants will receive enicepatide.

    Combination Product: Enicepatide

Interventions

  • Combination productEnicepatide

    Participants will receive enicepatide as per the schedule described in the protocol.

    Also known as: RO7795068, RG6640, CT-388

  • Combination productTirzepatide

    Participants will receive tirzepatide as per the schedule described in the protocol.

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline through Week 72

Secondary outcomes

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

    Time frame: At Week 72

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

    Time frame: At Week 72

  3. Change From Baseline to Week 72 in Fasting Glucose

    Time frame: Baseline through Week 72

  4. Percent Change From Baseline to Week 72 in Body Weight

    Time frame: Baseline through Week 72

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

    Time frame: At Week 72

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

    Time frame: Baseline through Week 72

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

    Time frame: At Week 72

  8. 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

  9. 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

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

    Time frame: At Week 72

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

    Time frame: At Week 72

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

    Time frame: At Week 72

  13. Change From Baseline to Week 72 in Waist Circumference

    Time frame: Baseline through Week 72

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

    Time frame: Baseline through Week 72

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

    Time frame: At Week 72

  16. Change From Baseline to Week 72 in Total Cholesterol

    Time frame: Baseline through Week 72

  17. Change from Baseline to Week 72 in Triglycerides

    Time frame: Baseline through Week 72

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

    Time frame: Baseline through Week 72

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

    Time frame: Baseline through Week 72

  20. Change From Baseline to Week 72 in Systolic Blood Pressure

    Time frame: Baseline through Week 72

  21. Change From Baseline to Week 72 in Diastolic Blood Pressure

    Time frame: Baseline through Week 72

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

    Time frame: Baseline through Week 72

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

    Time frame: Baseline through Week 72

  24. Incidence and Severity of Adverse Events

    Time frame: From Baseline up to Week 75

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Apr 2029, 28 months later.

Of 430 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's planned 28 months is above that.

Counting every sponsor, half of 510 studies reached it within 20 months; a quarter within 14 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2026
First posted
Oct 22, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Apr 2, 2029
CompletionEst.
Apr 23, 2029
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07889648
Lead sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Apr 2, 2029 (estimated)
Completion
Apr 23, 2029 (estimated)
Last update
Oct 22, 2026

Study contacts

Reference Study ID Number: WC45975 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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