ClinicalTrials.gg
CompletedNCT07321678Updated Oct 30, 2026

A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus

A Phase 2 interventional study of ASC30 tablets and Placebo in T2DM (Type 2 Diabetes Mellitus), sponsored by Ascletis Pharma (China) Co., Limited. Completed at 8 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Ascletis Pharma (China) Co., Limited (part of Ascletis Pharma Inc.) · Phase 2, Interventional, and Treatment

Updated Oct 30, 2026Primary outcomes revisedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 3,300 studies in Diabetes Mellitus, Type 2 with a site in United States — 340 open to participants now, 475 under way, 47 of them phase 3. Diabetes Mellitus, Type 2 · United States.

Enrollment
1,391st of 2,953
100 · median 90
Started
2026
with 148 others
Phase 2
391 of 3,300
24 open now
Registered
3,174th of 3,300
by date

Among the 3,300 studies in Diabetes Mellitus, Type 2 with a site in United States, this one is the 1,391st largest by enrollment of the 2,953 interventional ones that give a count, is one of 149 that started in 2026, is one of 391 in phase 2, and was the 3,174th registered.

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

340 of the 3,300 studies in Diabetes Mellitus, Type 2 with a site in United States are open now. Recruiting first, the newest first:

335 more — sign in →

All 340 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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

03

Conditions studied

  • T2DM (Type 2 Diabetes Mellitus)
04

Who can participate

Ages eligible
18 Years to 75 Years
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 Type 2 Diabetes (T2D)
  • Have ≥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 ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    ASC30 tablets Dose 1

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

    Drug: ASC30 tablets

  • Experimental
    ASC30 tablets Dose 2

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

    Drug: ASC30 tablets

  • Experimental
    ASC30 tablets Dose 3

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

    Drug: ASC30 tablets

  • Placebo comparator
    Placebo

    Participants will receive Placebo administered orally once daily.

    Drug: Placebo

Interventions

  • ASC30 tablets administered orally once daily

  • DrugPlacebo

    Placebo administered orally once daily

06

What researchers measure

Primary outcomes

  1. Mean change from baseline in HbA1c up to 12 weeks in the treatment group compared with the placebo group

    Time frame: Baseline and end of Week 12

Secondary outcomes

  1. Mean change from baseline in fasting blood glucose up to 12 weeks in the treatment group compared with the placebo group

    Time frame: Baseline and end of Week 12

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

    Time frame: Baseline and end of Week 13

07

Study locations

8 sites
  • Ascletis Clinical Site
    Riverside, California 92506, United States
  • Ascletis Clinical Site
    San Jose, California 95128, United States
  • Ascletis Clinical Site
    Denver, Colorado 80246, United States
  • Ascletis Clinical Site
    Miami, Florida 33143, United States
  • Ascletis Clinical Site
    Miami, Florida 33172, United States
  • Ascletis Clinical Site
    Decatur, Georgia 30030, United States
  • Ascletis Clinical Site
    Springfield, Missouri 65802, United States
  • Ascletis Clinical Site
    San Antonio, Texas 78240, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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

Ran from Jan 2026 to primary completion in Aug 2026, 6 months.

Of 194 industry-sponsored phase 2 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 18. This study's 6 months is below that.

Counting every sponsor, half of 293 studies reached it within 15 months; a quarter within 11 and three quarters within 27.

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

Registered
Jan 5, 2026
First posted
Jan 7, 2026
StartActual
Jan 22, 2026
Primary completionActual
Aug 10, 2026
CompletionActual
Aug 10, 2026
Last update
Oct 30, 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.
Primary outcomes
1 edited
What changed in the outcomes
  • EditedMean change from baseline in HbA1c up to 1312 weeks in the treatment group compared with the placebo groupTime frame: Baseline and end of Week 13 → Baseline and end of Week 12
Oct 30, 2026
Secondary outcomes
1 edited
What changed in the outcomes
  • EditedMean change from baseline in fasting blood glucose up to 1312 weeks in the treatment group compared with the placebo groupTime frame: Baseline and end of Week 13 → Baseline and end of Week 12
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedMean change from baseline in HbA1c up to 1312 weeks in the treatment group compared with the placebo groupTime frame: Baseline and end of Week 13 → Baseline and end of Week 12
    Secondary outcomes 1 edited
    What changed in the outcomes
    • EditedMean change from baseline in fasting blood glucose up to 1312 weeks in the treatment group compared with the placebo groupTime frame: Baseline and end of Week 13 → Baseline and end of Week 12

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
NCT07321678
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Jan 22, 2026
Primary completion
Aug 10, 2026
Completion
Aug 10, 2026
Last update
Oct 30, 2026

Oversight

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

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: ASC30

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