A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASC30 Injection in Participants With Obesity
NCT ID: NCT06679959
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
115 participants
INTERVENTIONAL
2024-09-16
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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SAD Cohort 1
SAD Dose 1
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
SAD Cohort 2
SAD Dose 2
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
SAD Cohort 3
SAD Dose 3
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
SAD Cohort 4
SAD Dose 4
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
SAD Cohort 5
SAD Dose 5
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
SAD Cohort 6
SAD Dose 6
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
SAD Cohort 7
SAD Dose 7
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
SAD Cohort 8
SAD Dose 8
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
MAD Cohort 1
MAD Dose 1
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
MAD Cohort 2
MAD Dose 2
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
MAD Cohort 3
MAD Dose 3
ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
Interventions
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ASC30 Injection, for subcutaneous use or placebo
Drug: ASC30 injection, for subcutaneous use Drug: Placebo injection, for subcutaneous use
Eligibility Criteria
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Inclusion Criteria
2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
3. No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
Exclusion Criteria
2. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
3. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
4. Have a history of acute or chronic pancreatitis.
5. Participants with a known clinically significant gastric emptying abnormality.
6. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
7. 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Ascletis Pharma (China) Co., Limited
INDUSTRY
Responsible Party
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Locations
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Ascletis clinical site
San Antonio, Texas, United States
Countries
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Other Identifiers
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ASC30-101
Identifier Type: -
Identifier Source: org_study_id
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