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RecruitingNCT07842640Updated Sep 25, 2026

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight

A Phase 1 interventional study of ASC35 Injection B, for subcutaneous use and ASC35 Placebo Injection B, for subcutaneous use in Chronic Weight Management, sponsored by Ascletis Pharma (China) Co., Limited. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Ascletis Pharma (China) Co., Limited (part of Ascletis Pharma Inc.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Weight Management
03

In context

Lead sponsor

Ascletis Pharma (China) Co., Limited is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Ascletis Pharma (China) Co., Limited studies →All Ascletis Pharma Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 given written 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 findings from medical history, physical examination, 12-lead , vital signs measurements, and other screening procedures.

Exclusion criteria

Exclusion Criteria:

  • Have evidence of any active or chronic disease.
  • Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
  • Have an disease, is 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 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.
Terms in these criteria, in plain language(6)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    SAD Cohort 1

    SAD Dose 1

    Drug: ASC35 Injection B, for subcutaneous use · Drug: ASC35 Placebo Injection B, for subcutaneous use

  • Experimental
    SAD Cohort 2

    SAD Dose 2

    Drug: ASC35 Injection B, for subcutaneous use · Drug: ASC35 Placebo Injection B, for subcutaneous use

  • Experimental
    SAD Cohort 3

    SAD Dose 3

    Drug: ASC35 Injection B, for subcutaneous use · Drug: ASC35 Placebo Injection B, for subcutaneous use

  • Experimental
    SAD Cohort 4

    SAD Dose 4

    Drug: ASC35 Injection B, for subcutaneous use · Drug: ASC35 Placebo Injection B, for subcutaneous use

  • Active comparator
    MAD Cohort 0

    MAD Cohort 0

    Drug: Tirzepatide

  • Experimental
    MAD Cohort 1

    MAD Cohort 1

    Drug: ASC35 Injection B, for subcutaneous use · Drug: ASC35 Placebo Injection B, for subcutaneous use

  • Experimental
    MAD Cohort 2

    MAD Cohort 2

    Drug: ASC35 Injection B, for subcutaneous use · Drug: ASC35 Placebo Injection B, for subcutaneous use

  • Experimental
    MAD Cohort 3

    MAD Cohort 3

    Drug: ASC35 Injection B, for subcutaneous use · Drug: ASC35 Placebo Injection B, for subcutaneous use

  • Experimental
    MAD Cohort 4

    MAD Cohort 4

    Drug: ASC35 Injection B, for subcutaneous use · Drug: ASC35 Placebo Injection B, for subcutaneous use

Interventions

  • DrugASC35 Injection B, for subcutaneous use

    ASC35 Injection B is an investigational once-monthly formulation of ASC35 administered by subcutaneous injection.

  • DrugASC35 Placebo Injection B, for subcutaneous use

    ASC35 Placebo Injection B is a placebo injection matching ASC35 Injection B

  • DrugTirzepatide

    Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist administered by subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Adverse events

    A summary of AEs, SAEs and other non-serious adverse events

    Time frame: Baseline and Day 141

Secondary outcomes

  1. Cmax of ASC35

    Evaluate the peak plasma concentration of ASC35

    Time frame: Baseline and Day 141

  2. Tmax of ASC35

    Evaluate the time to reach peak plasma concentration of ASC35

    Time frame: Baseline and Day 141

  3. AUC of ASC35

    Evaluate the area under the plasma concentration-time curve of ASC35

    Time frame: Baseline and Day 141

  4. Change From Baseline in Body Weight

    Percentage Change From Baseline in Body Weight

    Time frame: Baseline and Day 141

  5. Change From Baseline in Body Weight

    Actual Change From Baseline in Body Weight

    Time frame: Baseline and Day 141

07

Study locations

1 of 1 sites recruiting
  • Ascletis Clinical Site
    Baltimore, Maryland 21201, United States
    Recruiting
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 reached

Started Aug 2026 (actual). Primary completion is estimated for Jun 2027, 10 months after the start.

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

Registered
Sep 21, 2026
First posted
Sep 25, 2026
StartActual
Aug 27, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Sep 25, 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.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

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
NCT07842640
Lead sponsor
Ascletis Pharma (China) Co., Limited
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Aug 27, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Ascletis Recruiting
Contact
clinicaltrials@ascletis.com
+1 2068073688

Oversight

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

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