Chronic Weight ManagementPhase 1NCT06972992
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide
A Phase 1 study testing ASC47 +Semaglutide in people with Chronic Weight Management, run by Ascletis Pharma (China) Co., Limited at 1 site in United States.
Trial summary
This will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Weight Management
- What is being tested?
- ASC47 +Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2025to 22 Sep 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
- Subject have provided informed consent before initiation of any study specific procedures
- Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, e.g., Clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia as assessed by the Investigator (or sub-I).
- Stable body weight (less than 5% self-reported change within the previous 3 months)
Who cannot join
- Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.
- Have a history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year.
- Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 half-lives of the experimental agent (exception of placebo) prior to the start of the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection, for Subcutaneous Use in Combination With Semaglutide in Participants With Obesity
This will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
- Conditions
- Chronic Weight Management
- Being tested
- ASC47 +Semaglutide, Placebo+Semaglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC47 +SemaglutideDrug
ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks
Placebo+SemaglutideDrug
Placebo single subcutaneous injection + Semaglutide QW for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Combo Cohort 1 in participants with obesity | Experimental | Cohort 1, dose 1 Receives: Drug: ASC47 +Semaglutide; Drug: Placebo+Semaglutide |
| Combo Cohort 2 in participants with obesity | Experimental | Cohort 2, dose 2 Receives: Drug: ASC47 +Semaglutide; Drug: Placebo+Semaglutide |
| Combo Cohort 3 in participants with obesity | Experimental | Cohort 3, dose 3 Receives: Drug: ASC47 +Semaglutide; Drug: Placebo+Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Measured: up to 71 days
Secondary outcomes (5)
Change From Baseline in Body Weight
Change from baseline (week 1) to week 10 in body weight was evaluated
Measured: up to 71 days
Cmax of ASC47
Evaluate the Peak Plasma Concentration of ASC47 in combination with semaglutide.
Measured: up to 71 days
AUC of ASC47
Evaluate the Area under the plasma concentration versus time curve of ASC47 in combination with semaglutide.
Measured: up to 71 days
T1/2 of ASC47
Evaluate the Terminal-Phase Half-Life of ASC47 in combination with semaglutide.
Measured: up to 71 days
CL/F of ASC47
Evaluate the Apparent Systemic Clearance of ASC47 in combination with semaglutide.
Measured: up to 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start18 Apr 2025
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 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
- NCT06972992
- Sponsor's protocol ID
- ASC47-103
- Status last verified
- Sep 2025
- First submitted
- 7 May 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection, for Subcutaneous Use in Combination With Semaglutide in Participants With Obesity
- ClinicalTrials.gov ID
- NCT06972992
- Acronym / sponsor ID
- ASC47-103
- Conditions
- Chronic Weight Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ascletis Pharma (China) Co., LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 15 May 2025 (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 will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combo Cohort 1 in participants with obesity | Experimental | Drug: ASC47 +Semaglutide, Drug: Placebo+SemaglutideCohort 1, dose 1 |
| Combo Cohort 2 in participants with obesity | Experimental | Drug: ASC47 +Semaglutide, Drug: Placebo+SemaglutideCohort 2, dose 2 |
| Combo Cohort 3 in participants with obesity | Experimental | Drug: ASC47 +Semaglutide, Drug: Placebo+SemaglutideCohort 3, dose 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject have provided informed consent before initiation of any study specific procedures
- Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, e.g., Clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia as assessed by the Investigator (or sub-I).
- Stable body weight (less than 5% self-reported change within the previous 3 months)
Key exclusion criteria (5 listed)
- Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.
- Have a history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year.
- Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 half-lives of the experimental agent (exception of placebo) prior to the start of the treatment.
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 |
|---|---|---|
| ASC47 +SemaglutideASC47 single subcutaneous injection + Semaglutide QW for 4 weeks | Drug | Combo Cohort 1 in participants with obesity, Combo Cohort 2 in participants with obesity, Combo Cohort 3 in participants with obesity |
| Placebo+SemaglutidePlacebo single subcutaneous injection + Semaglutide QW for 4 weeks | Drug | Combo Cohort 1 in participants with obesity, Combo Cohort 2 in participants with obesity, Combo Cohort 3 in participants with obesity |
Primary outcome
Adverse events
Time frame: up to 71 days
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
5 secondary outcomes
Change From Baseline in Body Weight
Time frame: up to 71 days
Cmax of ASC47
Time frame: up to 71 days
AUC of ASC47
Time frame: up to 71 days
T1/2 of ASC47
Time frame: up to 71 days
CL/F of ASC47
Time frame: up to 71 days
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 18 Dec 2025.
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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 ASC47 +Semaglutide in people with Chronic 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 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 18 Dec 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?
Adverse events (time frame: up to 71 days). 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 18 Dec 2025.