Weight ManagementPhase 1NCT06680440
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASC30 Tablets and ASC30 Tablets A1 in Participants With Obesity
A Phase 1 study testing ASC30 in people with Weight Management, run by Ascletis Pharma (China) Co., Limited at 1 site in United States.
Trial summary
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of ASC30 Tablets or ASC30 Tablets A1 in participants with obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Management
- What is being tested?
- ASC30
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2024to 3 Apr 2025
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have provided informed consent before initiation of any study-specific procedures.
- Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
Who cannot join
- Have evidence of any clinically significant active or chronic disease.
- Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
- Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- Have a history of acute or chronic pancreatitis.
- Participants with a known clinically significant gastric emptying abnormality.
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
- Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Tablets in Participants With Obesity
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of ASC30 Tablets or ASC30 Tablets A1 in participants with obesity.
- Conditions
- Weight Management
- Being tested
- ASC30, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC30Drug
Tablet, QD
PlaceboOther
Tablets, QD
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | SAD dose 1 Receives: Drug: ASC30; Other: Placebo |
| SAD Cohort 2 | Experimental | SAD dose 2 Receives: Drug: ASC30; Other: Placebo |
| SAD Cohort 3 | Experimental | SAD dose 3 Receives: Drug: ASC30; Other: Placebo |
| SAD Cohort 4 | Experimental | SAD dose 4 Receives: Drug: ASC30; Other: Placebo |
| SAD Cohort 5 | Experimental | SAD dose 5 Receives: Drug: ASC30; Other: Placebo |
| MAD Cohort 1 | Experimental | MAD dose 1 Receives: Drug: ASC30; Other: Placebo |
| MAD Cohort 2 | Experimental | MAD dose 2 Receives: Drug: ASC30; Other: Placebo |
| MAD Cohort 3 | Experimental | MAD dose 3 Receives: Drug: ASC30; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD)
A summary of AEs, SAEs and other non-serious adverse events
Measured: Up to Day 8
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (MAD)
A summary of AEs, SAEs and other non-serious adverse events
Measured: Up to Day 28
Secondary outcomes (3)
Cmax of ASC30 (SAD)
PK parameters of ASC30
Measured: Up to Day 8
Cmax of ASC30 (MAD)
PK parameters of ASC30
Measured: Up to Day 28
Change From Baseline in Body Weight (MAD)
Change From Baseline in Body Weight
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start26 Aug 2024
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 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
- NCT06680440
- Sponsor's protocol ID
- ASC30-102
- Status last verified
- Sep 2024
- First submitted
- 30 Oct 2024
- Last updated
- 20 May 2025
- 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 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Tablets in Participants With Obesity
- ClinicalTrials.gov ID
- NCT06680440
- Acronym / sponsor ID
- ASC30-102
- Conditions
- Weight Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ascletis Pharma (China) Co., LimitedIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 8 Nov 2024 (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 is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of ASC30 Tablets or ASC30 Tablets A1 in participants with obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: ASC30, Other: PlaceboSAD dose 1 |
| SAD Cohort 2 | Experimental | Drug: ASC30, Other: PlaceboSAD dose 2 |
| SAD Cohort 3 | Experimental | Drug: ASC30, Other: PlaceboSAD dose 3 |
| SAD Cohort 4 | Experimental | Drug: ASC30, Other: PlaceboSAD dose 4 |
| SAD Cohort 5 | Experimental | Drug: ASC30, Other: PlaceboSAD dose 5 |
| MAD Cohort 1 | Experimental | Drug: ASC30, Other: PlaceboMAD dose 1 |
| MAD Cohort 2 | Experimental | Drug: ASC30, Other: PlaceboMAD dose 2 |
| MAD Cohort 3 | Experimental | Drug: ASC30, Other: PlaceboMAD dose 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have provided informed consent before initiation of any study-specific procedures.
- Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
Key exclusion criteria (7 listed)
- Have evidence of any clinically significant active or chronic disease.
- Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
- Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- Have a history of acute or chronic pancreatitis.
- Participants with a known clinically significant gastric emptying abnormality.
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 |
|---|---|---|
| ASC30Tablet, QD | Drug | MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4, SAD Cohort 5 |
| PlaceboTablets, QD | Other | MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4, SAD Cohort 5 |
Primary outcome
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD)
Time frame: Up to Day 8
A summary of AEs, SAEs and other non-serious adverse events
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (MAD)
Time frame: Up to Day 28
A summary of AEs, SAEs and other non-serious adverse events
3 secondary outcomes
Cmax of ASC30 (SAD)
Time frame: Up to Day 8
Cmax of ASC30 (MAD)
Time frame: Up to Day 28
Change From Baseline in Body Weight (MAD)
Time frame: Up to Day 28
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 20 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASC30 in people with Weight Management, run by Ascletis Pharma (China) Co., Limited at 1 site 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 3 inclusion and 7 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 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD) (time frame: Up to Day 8). The study lists 2 primary outcomes in all. 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 20 May 2025.