A Study to Evaluate the Efficacy and Safety of AD-233A, AD-233B, AD-233C and/or AD-233D Combination Therapy

NCT07816198 — Phase 3, Not yet recruiting, 354 participants, Addpharma Inc.
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A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of AD-233A, AD-233B, AD-233C and/or AD-233D Combination Therapy in Patients With Type 2 Diabetes Mellitus

RegistryNCT07816198
StatusNot yet recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment354 (Estimated)
SponsorAddpharma Inc. (Industry)
ConditionsType 2 Diabetes Mellitus (T2DM)
InterventionsAD-233A, AD-233B, AD-233C, AD-233D, AD-233A Placebo, AD-233B Placebo (Drug)
Datesstart 2026-09-30 (estimated), primary completion 2028-06-30 (estimated), completion 2028-06-30 (estimated), first posted 2026-09-11, last updated 2026-09-16

Related Papers Related Patents Related Grants Related Experts
All trials for Type 2 Diabetes Mellitus (T2DM) All trials of AD-233A All trials of AD-233B

-Summary

The purpose of this study is to evaluate the efficacy and safety of AD-233A, AD-233B, AD-233C and/or AD-233D combination therapy

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+Detailed description

Condition or disease: Type 2 Diabetes Mellitus

+Arms and interventions

ArmTypeInterventionsDescription
Test GroupExperimentalDrug: AD-233A; Drug: AD-233B; Drug: AD-233C; Drug: AD-233DAD-233A+AD-233B+AD-233C and/or AD-233D
Control Group 1Active comparatorDrug: AD-233B; Drug: AD-233C; Drug: AD-233D; Drug: AD-233A PlaceboAD-233A Placebo+AD-233B+AD-233C and/or AD-233D
Control Group 2Active comparatorDrug: AD-233A; Drug: AD-233C; Drug: AD-233D; Drug: AD-233B PlaceboAD-233A+AD-233B Placebo+AD-233C and/or AD-233D
  • AD-233A (Drug): PO, Once daily(QD), 24 weeks
  • AD-233B (Drug): PO, Once daily(QD), 24 weeks
  • AD-233C (Drug): PO, Once daily(QD), 24 weeks
  • AD-233D (Drug): PO, Once daily(QD), 24 weeks
  • AD-233A Placebo (Drug): PO, Once daily(QD), 24 weeks
  • AD-233B Placebo (Drug): PO, Once daily(QD), 24 weeks

+Outcome measures

Primary outcomes

  • Change in HbA1c(Hemoglobin a1c) from baseline at Week 24 after administration of IP(Investigator's Product) [Baseline, Week 24]

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

* Signed informed consent
* Other inclusions applied

Exclusion Criteria:

* Subjects with severe diabetic complications
* Other exclusions applied