Chronic Weight ManagementPhase 1NCT07842640
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight
A Phase 1 study testing ASC35 Injection B, for subcutaneous use and Tirzepatide in people with Chronic Weight Management, run by Ascletis Pharma (China) Co., Limited at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection 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?
- ASC35 Injection B, for subcutaneous use and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2026to Jun 2027
- Phase
- Phase 1
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 given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site.
- Are between 18 and 65 years of age (both inclusive) at time of screening.
- 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), history of ketoacidosis, or hyperosmolar state/coma.
- Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- Have a history of acute or chronic pancreatitis.
- Have 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ascletis Clinical Site
Baltimore, Maryland, 21201
Ascletis Recruiting, clinicaltrials@ascletis.com
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight
This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection
- Conditions
- Chronic Weight Management
- Being tested
- ASC35 Injection B, for subcutaneous use, ASC35 Placebo Injection B, for subcutaneous use, Tirzepatide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC35 Injection B, for subcutaneous useDrug
ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.
ASC35 Placebo Injection B, for subcutaneous useDrug
ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B
TirzepatideDrug
Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | SAD Dose 1 Receives: Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use |
| SAD Cohort 2 | Experimental | SAD Dose 2 Receives: Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use |
| SAD Cohort 3 | Experimental | SAD Dose 3 Receives: Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use |
| SAD Cohort 4 | Experimental | SAD Dose 4 Receives: Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use |
| MAD Cohort 0 | Active comparator | MAD Cohort 0 Receives: Drug: Tirzepatide |
| MAD Cohort 1 | Experimental | MAD Cohort 1 Receives: Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use |
| MAD Cohort 2 | Experimental | MAD Cohort 2 Receives: Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use |
| MAD Cohort 3 | Experimental | MAD Cohort 3 Receives: Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use |
| MAD Cohort 4 | Experimental | MAD Cohort 4 Receives: Drug: ASC35 Injection B, for subcutaneous use; Drug: ASC35 Placebo Injection B, for subcutaneous use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
A summary of AEs, SAEs and other non-serious adverse events
Measured: Baseline and Day 141
Secondary outcomes (5)
Cmax of ASC35
Evaluate the peak plasma concentration of ASC35
Measured: Baseline and Day 141
Tmax of ASC35
Evaluate the time to reach peak plasma concentration of ASC35
Measured: Baseline and Day 141
AUC of ASC35
Evaluate the area under the plasma concentration-time curve of ASC35
Measured: Baseline and Day 141
Change From Baseline in Body Weight
Percentage Change From Baseline in Body Weight
Measured: Baseline and Day 141
Change From Baseline in Body Weight
Actual Change From Baseline in Body Weight
Measured: Baseline and Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start27 Aug 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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
- 84 participants (estimated)
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
- NCT07842640
- Sponsor's protocol ID
- ASC35-101
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No