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Chronic Weight ManagementPhase 2NCT07002905

A Study to Evaluate the Efficacy, Safety, and Tolerability in Participants With Obesity or Overweight With Weight-Related Comorbidities

A Phase 2 study of Chronic Weight Management, run by Ascletis Pharma (China) Co., Limited at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized, double-blind, placebo-controlled phase IIa study is designed to evaluate the efficacy, safety, and tolerability of ASC30 Tablets and ASC30 Tablets A1. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Weight Management
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
6 sitesUnited States
Study dates
3 Jul 2025to 8 Dec 2025
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • 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 75 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

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Ascletis Clinical Site

    Bellaire, Texas, 77401

  • Ascletis Clinical Site

    Columbus, Ohio, 43212

  • Ascletis Clinical Site

    Fort Myers, Florida, 33912

  • Ascletis Clinical Site

    Miami, Florida, 33172

  • Ascletis Clinical Site

    Rogers, Arkansas, 72758

  • Ascletis Clinical Site

    San Antonio, Texas, 78240

Other trials in United States

About this study

Official title: A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets and ASC30 Tablets A1 in Participants With Obesity or Overweight With Weight-Related Comorbidities

This randomized, double-blind, placebo-controlled phase IIa study is designed to evaluate the efficacy, safety, and tolerability of ASC30 Tablets and ASC30 Tablets A1.

Being tested
ASC30 tablets or ASC30 tablets A1 or placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASC30 tablets or ASC30 tablets A1 or placeboDrug

    Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily

Study groups in NCT07002905
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Receives: Drug: ASC30 tablets or ASC30 tablets A1 or placebo
Cohort 2ExperimentalParticipants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Receives: Drug: ASC30 tablets or ASC30 tablets A1 or placebo
Cohort 3ExperimentalParticipants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Receives: Drug: ASC30 tablets or ASC30 tablets A1 or placebo
Cohort 4ExperimentalParticipants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Receives: Drug: ASC30 tablets or ASC30 tablets A1 or placebo
Cohort 5ExperimentalParticipants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Receives: Drug: ASC30 tablets or ASC30 tablets A1 or placebo
Cohort 6ExperimentalParticipants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Receives: Drug: ASC30 tablets or ASC30 tablets A1 or placebo
Cohort 7ExperimentalParticipants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Receives: Drug: ASC30 tablets or ASC30 tablets A1 or placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in body weight from Baseline up to Week 13

    Measured: Baseline and Week 13

Secondary outcomes (4)

  1. Change in body weight (absolute) from Baseline up to Week 13

    Measured: Baseline and Week 13

  2. Change in waist circumference from Baseline up to Week 13

    Measured: Baseline and Week 13

  3. Change in body mass index from Baseline to Week 13

    Measured: Baseline and Week 13

  4. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Measured: Baseline and Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study start3 Jul 2025
  3. Primary completion8 Dec 2025
  4. Study completion8 Dec 2025

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002905
Sponsor's protocol ID
ASC30-202
Status last verified
Dec 2025
First submitted
15 May 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Chronic Weight Management, run by Ascletis Pharma (China) Co., Limited at 6 sites 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 15 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 6 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Percent change in body weight from Baseline up to Week 13 (time frame: Baseline and Week 13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07002905.

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 15 Dec 2025.

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