Overweight and ObesityPhase 1NCT04686994
Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects
A Phase 1 study testing ASC 41 in people with Overweight and Obesity and NAFLD, run by Gannex Pharma Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C . Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, NAFLD, Hyperlipidemia
- What is being tested?
- ASC 41
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2020to 7 Feb 2021
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 23kg/m2 ≤ BMI <40kg/m2.
Who cannot join
- A history of thyroid disease.
- A positive HBsAg, HCV Ab and/or HIV Ab.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC41 Tables in Overweight and Obese Subjects
The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C .
- Conditions
- Overweight and Obesity, NAFLD, Hyperlipidemia
- Being tested
- ASC 41, ASC 41 Placebo
- Keywords
- Overweight and Obesity, NAFLD, Hyperlipidemia, LDL-C, NASH
- Medical subject headings
- Overweight, Obesity, Non-alcoholic Fatty Liver Disease, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC 41Drug
Oral tablets
ASC 41 PlaceboDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| ASC41 | Experimental | ASC41 two tablets, once daily, from Day 1 to Day 28. Receives: Drug: ASC 41 |
| ASC41 placebo | Placebo comparator | ASC41 placebo two tablets, once daily, from Day 1 to Day 28. Receives: Drug: ASC 41 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 28 days
Measured: Up to 28 days
Secondary outcomes (7)
AUC of ASC41
Evaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets.
Measured: Up to 28 days
Cmax of ASC41
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.
Measured: Up to 28 days
t1/2 of ASC41
Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables.
Measured: Up to 28 days
CL/F of ASC41
Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
Measured: Up to 28 days
Vd/F of ASC41
Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
Measured: Up to 28 days
Tmax of ASC41
Evaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables.
Measured: Up to 28 days
LDL-C and other lipid parameters
To evaluate the effect of multiple doses of ASC41 tablets on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) .
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start22 Dec 2020
- Primary completion19 Jan 2021
- Study completion7 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Parallel groups
- Model description
- Parallel Assignment 3:1 ratio
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gannex Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686994
- Sponsor's protocol ID
- ASC41-104
- Status last verified
- Sep 2024
- First submitted
- 23 Dec 2020
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC41 Tables in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT04686994
- Acronym / sponsor ID
- ASC41-104
- Conditions
- Overweight and Obesity, NAFLD, Hyperlipidemia
- Keywords
- Overweight and Obesity, NAFLD, Hyperlipidemia, LDL-C, NASH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gannex Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial People's Hospital
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 7 Feb 2021 (actual)
- First posted
- 29 Dec 2020 (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.
The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment 3:1 ratio
| Arm | Type | Receives |
|---|---|---|
| ASC41 | Experimental | Drug: ASC 41ASC41 two tablets, once daily, from Day 1 to Day 28. |
| ASC41 placebo | Placebo comparator | Drug: ASC 41 PlaceboASC41 placebo two tablets, once daily, from Day 1 to Day 28. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 23kg/m2 ≤ BMI <40kg/m2.
Key exclusion criteria (2 listed)
- A history of thyroid disease.
- A positive HBsAg, HCV Ab and/or HIV Ab.
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 |
|---|---|---|
| ASC 41Oral tablets | Drug | ASC41 |
| ASC 41 PlaceboOral tablets | Drug | ASC41 placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 28 days
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 28 days
7 secondary outcomes
AUC of ASC41
Time frame: Up to 28 days
Cmax of ASC41
Time frame: Up to 28 days
t1/2 of ASC41
Time frame: Up to 28 days
CL/F of ASC41
Time frame: Up to 28 days
Vd/F of ASC41
Time frame: Up to 28 days
Tmax of ASC41
Time frame: Up to 28 days
LDL-C and other lipid parameters
Time frame: Up to 28 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 27 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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 ASC 41 in people with Overweight and Obesity and NAFLD, run by Gannex Pharma Co., Ltd. at 1 site in China.
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 1 inclusion and 2 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 27 Sep 2024. 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 China. 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. Some participants in this study may receive a placebo. 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to 28 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 27 Sep 2024.