NCT07321678

Brief Summary

This randomized, double-blind, placebo-controlled Phase II study is designed to evaluate the efficacy, safety, and tolerability of ASC30 oral tablets formulation in participants with Type 2 Diabetes Mellitus

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
2mo left

Started Jan 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

January 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

January 5, 2026

Last Update Submit

April 26, 2026

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group

    Baseline and end of Week 13

Secondary Outcomes (2)

  • Mean change from baseline in fasting blood glucose up to 13 weeks in the treatment group compared with the placebo group

    Baseline and end of Week 13

  • Mean change from baseline in body weight up to 13 weeks in the treatment group compared with placebo group

    Baseline and end of Week 13

Study Arms (4)

ASC30 tablets Dose 1

EXPERIMENTAL

Participants will receive ASC30 tablets Dose 1 administered orally once daily.

Drug: ASC30 tablets

ASC30 tablets Dose 2

EXPERIMENTAL

Participants will receive ASC30 tablets Dose 2 administered orally once daily.

Drug: ASC30 tablets

ASC30 tablets Dose 3

EXPERIMENTAL

Participants will receive ASC30 tablets Dose 3 administered orally once daily.

Drug: ASC30 tablets

Placebo

PLACEBO COMPARATOR

Participants will receive Placebo administered orally once daily.

Drug: Placebo

Interventions

PlaceboDRUG

Placebo administered orally once daily

Placebo
ASC30 tabletsDRUG

ASC30 tablets administered orally once daily

ASC30 tablets Dose 1ASC30 tablets Dose 2ASC30 tablets Dose 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have Type 2 Diabetes (T2D)
  • Have HbA1c ≥7.0% to ≤10.5% as determined by the central laboratory at screening.
  • Stable body weight (less than 5% self-reported change within the previous 3 months).
  • Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.

You may not qualify if:

  • Have any prior diagnosis of type 1 diabetes mellitus (T1DM), or rare forms of diabetes mellitus
  • Have had more than 1 episode of severe hypoglycemia
  • Have poorly controlled hypertension
  • Have acute or chronic hepatitis and pancreatitis
  • Have evidence of a significant active and uncontrolled medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ascletis Clinical Site

Riverside, California, 92506, United States

Location

Ascletis Clinical Site

San Jose, California, 95128, United States

Location

Ascletis Clinical Site

Denver, Colorado, 80246, United States

Location

Ascletis Clinical Site

Miami, Florida, 33143, United States

Location

Ascletis Clinical Site

Miami, Florida, 33172, United States

Location

Ascletis Clinical Site

Decatur, Georgia, 30030, United States

Location

Ascletis Clinical Site

Springfield, Missouri, 65802, United States

Location

Ascletis Clinical Site

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 7, 2026

Study Start

January 22, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(8)