T2DM (Type 2 Diabetes Mellitus)Phase 2NCT07321678
A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus
A Phase 2 study testing ASC30 tablets in people with T2DM (Type 2 Diabetes Mellitus), run by Ascletis Pharma (China) Co., Limited at 8 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- ASC30 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 8 sitesUnited States
- Study dates
- 22 Jan 2026to 10 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Ascletis Clinical Site
Decatur, Georgia, 30030
Ascletis Clinical Site
Denver, Colorado, 80246
Ascletis Clinical Site
Miami, Florida, 33143
Ascletis Clinical Site
Miami, Florida, 33172
Ascletis Clinical Site
Riverside, California, 92506
Ascletis Clinical Site
San Antonio, Texas, 78240
Ascletis Clinical Site
San Jose, California, 95128
Ascletis Clinical Site
Springfield, Missouri, 65802
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus
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
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- ASC30 tablets, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC30 tabletsDrug
ASC30 tablets administered orally once daily
PlaceboDrug
Placebo administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| ASC30 tablets Dose 1 | Experimental | Participants will receive ASC30 tablets Dose 1 administered orally once daily. Receives: Drug: ASC30 tablets |
| ASC30 tablets Dose 2 | Experimental | Participants will receive ASC30 tablets Dose 2 administered orally once daily. Receives: Drug: ASC30 tablets |
| ASC30 tablets Dose 3 | Experimental | Participants will receive ASC30 tablets Dose 3 administered orally once daily. Receives: Drug: ASC30 tablets |
| Placebo | Placebo comparator | Participants will receive Placebo administered orally once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in HbA1c up to 12 weeks in the treatment group compared with the placebo group
Measured: Baseline and end of Week 12
Secondary outcomes (2)
Mean change from baseline in fasting blood glucose up to 12 weeks in the treatment group compared with the placebo group
Measured: Baseline and end of Week 12
Mean change from baseline in body weight up to 13 weeks in the treatment group compared with placebo group
Measured: Baseline and end of Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start22 Jan 2026
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharma (China) Co., Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321678
- Sponsor's protocol ID
- ASC30-203
- Status last verified
- Sep 2026
- First submitted
- 5 Jan 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07321678
- Acronym / sponsor ID
- ASC30-203
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ascletis Pharma (China) Co., LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASC30 tablets Dose 1 | Experimental | Drug: ASC30 tabletsParticipants will receive ASC30 tablets Dose 1 administered orally once daily. |
| ASC30 tablets Dose 2 | Experimental | Drug: ASC30 tabletsParticipants will receive ASC30 tablets Dose 2 administered orally once daily. |
| ASC30 tablets Dose 3 | Experimental | Drug: ASC30 tabletsParticipants will receive ASC30 tablets Dose 3 administered orally once daily. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive Placebo administered orally once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASC30 tabletsASC30 tablets administered orally once daily | Drug | ASC30 tablets Dose 1, ASC30 tablets Dose 2, ASC30 tablets Dose 3 |
| PlaceboPlacebo administered orally once daily | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASC30 tablets in people with T2DM (Type 2 Diabetes Mellitus), run by Ascletis Pharma (China) Co., Limited at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.