Atherosclerosis Cardiovascular DiseasePhase 2NCT07303777
Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis
A Phase 2 study testing ABP-745 Dose A, ABP-745 Dose B and ABP-745 Dose C in people with Atherosclerosis Cardiovascular Disease and ASCVD, run by Atom Therapeutics Co., Ltd at 33 sites in 3 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the preliminary efficacy, safety, and PopPK profile of ABP-745 in patients with ASCVD. Efficacy of ABP-745 in reducing atherosclerotic plaque compared with placebo will be evaluated in participants with ASCVD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherosclerosis Cardiovascular Disease, ASCVD, ASCVD Management
- What is being tested?
- ABP-745 Dose A, ABP-745 Dose B and ABP-745 Dose C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 33 sitesin 3 countries
- Study dates
- 23 Apr 2026to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Unless otherwise specified, subjects must meet all of the following criteria at screening:
- Diagnosed with coronary at herosclerosis, and coronary angiography.
- Male or female at 18-75 years of age (inclusive).
- Weight ≥40 kg.
- Currently using any oral lipid-lowering therapy.
- Able to understand and willing to sign an ICF and comply with study requirements.
- A woman or man of childbearing potential agreeing to use medically approved contraceptive methods from the screening until 3 months after the last study dose.
Who cannot join
- Unless otherwise specified, subjects are excluded from the study if any of the following criteria is met:
- History of stroke within the past 6 months.
- Uncontrolled arrhythmia within 3 months prior to screening.
- Evidence of any active or suspected cancer within 3 years prior to the screening.
- Having undergone any major surgery within 3 months prior to the screening or planning to undergo any major surgery during the study.
- Presence or suspicion of ongoing of any serious infection.
- Human immunodeficiency virus (HIV) infection.
Trial locations and contacts
33 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 3 countries
China24 sites, 24 recruiting
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Ping Wang
- Not yet recruiting
Peking Union Medical College Hospital
Beijing
Zhenyu Liu
- Not yet recruiting
Peking University First Hospital
Beijing
Yan Zhang
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing
Chunlin Yin
- Not yet recruiting
Dalian Second Hospital
Dalian
Xin Zhao
- Not yet recruiting
Guangdong Province Hospital
Guangzhou
Jiyan Chen
- Not yet recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou
Guosheng Fu
- Not yet recruiting
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou
Xiaogang Guo
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou
Lihong Wang
- Not yet recruiting
Jinan Central Hospital
Jinan
Guohai Su
- Not yet recruiting
Jiangsu Province Hospital
Nanjing
Chunjian Li
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing
Biao Xu
- Not yet recruiting
Huashan Hospital Fudan University
Shanghai
Jian Li
- Not yet recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Jun Bu
- Not yet recruiting
Shanghai General Hospital
Shanghai
Shaowen Liu
- Recruiting
The Zhongshan Hospital Affiliated to Fudan University
Shanghai
Junbo Ge, M.D.
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Tingbo Jiang
- Not yet recruiting
Tianjin General Hospital
Tianjin
Qing Yang
- Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan
Xiaoyan Li
- Not yet recruiting
Wuxi People's Hospital
Wuxi
Ruxing Wang
- Not yet recruiting
Shaanxi Provincial People's Hospital
Xi'an
Junkui Wang
- Not yet recruiting
The First Affiliated Hospital of Xian Jiaotong University
Xi'an
Zuyi Yuan
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Jie Deng
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou
Dengfeng Pan
Australia5 sites, 5 recruiting
- Not yet recruiting
Core Research Group Pty Ltd
Brisbane
Colquhoun David, M.D.
- Not yet recruiting
UniSC Clinical Trials (Brisbane)
Brisbane
Nsahai Sahai, M.D., nsahai@usc.edu.au
Nsahai Sahai, M.D.
- Not yet recruiting
University of the Sunshine Coast Clinical Trials Unit - Morayfield
Morayfield, Queensland, 4506
Chris Moller, M.D.
Chris Moller, M.D.
- Not yet recruiting
NovaTrails
Newcastle, New South Wales, 2290
Oscar Cumming, M.D., Renata.fuljahn@novatrials.com.au
Oscar Cumming
- Not yet recruiting
Cognivus
Wahroonga
Elizabeth Shaw, MBBS
United States4 sites, 4 recruiting
- Not yet recruiting
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, 90210
Ronald P. Karlsberg, (310) 278-3400, Karlsberg@cvmg.com
Ronald P. Karlsberg
- Not yet recruiting
Cardiovascular Institute of San Diego INC
San Diego, California, 91911
Milind M. Parikh, M.D., 619-616-2100, Milind.Parikh@cvisd.com
Milind Parikh, M.D.
- Not yet recruiting
Washington University School of Medicine, St.louis
St Louis, Missouri, 63130
Farhan M. Katchi, M.D., 314-362-1291, katchif@wustl.edu
Farhan M. Katchi, M.D.
- Not yet recruiting
The Lundquist Institute
Torrance, California, 90502
Matthew Budoff, M.D., (424) 201-3000, mbudoff@lundquist.org
Matthew Budoff, M.D.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics (PopPK) Profile of ABP-745 in Patients With Atherosclerosis
This is a multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the preliminary efficacy, safety, and PopPK profile of ABP-745 in patients with ASCVD. Efficacy of ABP-745 in reducing atherosclerotic plaque compared with placebo will be evaluated in participants with ASCVD. The primary efficacy measurement will be assessed at 52W of treatment.
- Being tested
- ABP-745 Dose A, Placebo, ABP-745 Dose B, ABP-745 Dose C
- Keywords
- ASCVD, ABP-745
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP-745 Dose ADrug
ABP-745 Dose A - tablets (PO), low dose , QD
PlaceboDrug
ABP-745 placebo - tablets (PO), non-active,QD
ABP-745 Dose BDrug
ABP-745 Dose B - tablets (PO), Midum dose, QD
ABP-745 Dose CDrug
ABP-745 Dose C - tablets (PO), High dose, QD
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Existing lipid-lowering maintenance medications unchanged. Receives: Drug: Placebo |
| ABP-745 Dose A | Experimental | Existing lipid-lowering maintenance medications unchanged. Receives: Drug: ABP-745 Dose A |
| ABP-745 Dose B | Experimental | Existing lipid-lowering maintenance medications unchanged. Receives: Drug: ABP-745 Dose B |
| ABP-745 Dose C | Experimental | Existing lipid-lowering maintenance medications unchanged. Receives: Drug: ABP-745 Dose C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline in percent atheroma volume (PAV)
Measured: 52 weeks after treatment
Secondary outcomes (2)
Change from the baseline in percent atheroma volume (PAV)
Measured: 24 weeks after treatment
Incidence of treatment-emergent adverse events (Safety and Tolerability) TEAEs and SAEs, and clinically significant changes in physical examination, vital signs, safety laboratory tests, and 12-lead ECG.
Measured: up to 14 days post the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start23 Apr 2026
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis Cardiovascular DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atom Therapeutics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303777
- Sponsor's protocol ID
- ABP-745-202
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no such demand at present.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics (PopPK) Profile of ABP-745 in Patients With Atherosclerosis
- ClinicalTrials.gov ID
- NCT07303777
- Acronym / sponsor ID
- ABP-745-202
- Keywords
- ASCVD, ABP-745
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Atom Therapeutics Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 26 Dec 2025 (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.
This is a multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the preliminary efficacy, safety, and PopPK profile of ABP-745 in patients with ASCVD. Efficacy of ABP-745 in reducing atherosclerotic plaque compared with placebo will be evaluated in participants with ASCVD. The primary efficacy measurement will be assessed at 52W of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: PlaceboExisting lipid-lowering maintenance medications unchanged. |
| ABP-745 Dose A | Experimental | Drug: ABP-745 Dose AExisting lipid-lowering maintenance medications unchanged. |
| ABP-745 Dose B | Experimental | Drug: ABP-745 Dose BExisting lipid-lowering maintenance medications unchanged. |
| ABP-745 Dose C | Experimental | Drug: ABP-745 Dose CExisting lipid-lowering maintenance medications unchanged. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unless otherwise specified, subjects must meet all of the following criteria at screening:
- Diagnosed with coronary at herosclerosis, and coronary angiography.
- Male or female at 18-75 years of age (inclusive).
- Weight ≥40 kg.
- Currently using any oral lipid-lowering therapy.
Key exclusion criteria (7 listed)
- Unless otherwise specified, subjects are excluded from the study if any of the following criteria is met:
- History of stroke within the past 6 months.
- Uncontrolled arrhythmia within 3 months prior to screening.
- Evidence of any active or suspected cancer within 3 years prior to the screening.
- Having undergone any major surgery within 3 months prior to the screening or planning to undergo any major surgery during the study.
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 |
|---|---|---|
| ABP-745 Dose AABP-745 Dose A - tablets (PO), low dose , QD | Drug | ABP-745 Dose A |
| PlaceboABP-745 placebo - tablets (PO), non-active,QD | Drug | Placebo group |
| ABP-745 Dose BABP-745 Dose B - tablets (PO), Midum dose, QD | Drug | ABP-745 Dose B |
| ABP-745 Dose CABP-745 Dose C - tablets (PO), High dose, QD | Drug | ABP-745 Dose C |
Primary outcome
Change from the baseline in percent atheroma volume (PAV)
Time frame: 52 weeks after treatment
2 secondary outcomes
Change from the baseline in percent atheroma volume (PAV)
Time frame: 24 weeks after treatment
Incidence of treatment-emergent adverse events (Safety and Tolerability) TEAEs and SAEs, and clinically significant changes in physical examination, vital signs, safety laboratory tests, and 12-lead ECG.
Time frame: up to 14 days post the last dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No. There is no such demand at present.
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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.
33 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABP-745 Dose A, ABP-745 Dose B and ABP-745 Dose C in people with Atherosclerosis Cardiovascular Disease and ASCVD, run by Atom Therapeutics Co., Ltd at 33 sites in 3 countries.
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 7 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in China, Australia, 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. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Shi (86+ 19117302212, qiang.shi@atombp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline in percent atheroma volume (PAV) (time frame: 52 weeks after treatment). 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 28 Apr 2026.