Mixed DyslipidemiaPhase 2NCT06497127
A Study in Patients With Mixed Dyslipidemia
A Phase 2 study testing BW-00112 in people with Mixed Dyslipidemia, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 14 sites in United States.
Trial summary
A Phase 2 in Patients With Mixed Dyslipidemia Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mixed Dyslipidemia
- What is being tested?
- BW-00112
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 14 sitesUnited States
- Study dates
- 28 Feb 2024to 30 Mar 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
- Must have given written informed consent and be able to comply with all study requirements.
- Males or females aged 18 to 75 aged years, inclusive, at the time of informed consent
- Fasting LDL-C ≥ 70 mg/dL [1.8 mmol/L] at Screening.
- 4.150 mg/dL [1.7 mmol/L] ≤ fasting TG < 500 mg/dL [5.6 mmol/L] at Screening, which may be repeated once if deemed necessary.
- 5.On a stable statin for at least 1 month before Screening and plan to remain on the same medication and dose for the duration of the study.
- 6.Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal 7.Male patients agreeing to use acceptable methods of contraception
Who cannot join
- Active pancreatitis within 12 weeks prior to Day 1.
- Clinically significant acute cardiovascular even or procedure
- HbA1c > 9.0% at Screening or patients with diabetes who have experienced diabetic ketoacidosis, diabetic decompensation, hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks prior to Day 1.
- Presence of any clinically significant uncontrolled disease known to influence serum lipids or lipoproteins. NOTE: Patients on thyroid replacement therapy are eligible if the dosage of thyroxine has been stable for at least 12 weeks prior to Day 1.
- Use of TG lowering medication , non-prescription dietary supplements or other cholesterol lowering medication 30 days prior to Day 1, other than statins and ezetimibe.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Excel Medical Clinical Trials, LLC, dba Flourish Research
Boca Raton, Florida, 33434
East Coast Institute for Research LLC
Canton, Georgia, 30114
Alliance for Multispecialty Research, LLC
Daphne, Alabama, 36526
East Coast Institute for Research, LLC
Jacksonville, Florida, 32204
Clinical Site Partners Leesburg, LLC dba Flourish Research
Leesburg, Florida, 34748
Suncoast Research Group, LLC DBA Flourish Research
Miami, Florida, 33135
Clinical Site Partners, LLC DBA Flourish Research
Miami, Florida, 33186
Alliance for Multispecialty Research, LLC
Mobile, Alabama, 36608
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6574
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
Alliance for Multispecialty Research, LLC
Oak Brook, Illinois, 60523
Alliance for Multispecialty Research, LLC
Park Ridge, Illinois, 60068
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Subcutaneously Administered BW-00112 in Patients With Mixed Dyslipidemia
A Phase 2 in Patients With Mixed Dyslipidemia
Read the detailed description
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Subcutaneously Administered BW-00112 in Patients with Mixed Dyslipidemia
- Conditions
- Mixed Dyslipidemia
- Being tested
- BW-00112
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BW-00112Drug
BW-00112 or volume-matched placebo on Day 1 and Day 90
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | BW-00112 150 mg or volume-matched placebo on Day 1 and Day 90 Receives: Drug: BW-00112 |
| Cohort 2 | Experimental | BW-00112 300 mg or volume-matched placebo on Day 1 and Day 90 Receives: Drug: BW-00112 |
| Cohort 3 | Experimental | BW-00112 600 mg or volume-matched placebo on Day 1 and Day 90 Receives: Drug: BW-00112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in fasting TG
Percent change in fasting TG from baseline to Day 180
Measured: From baseline to Day 180
Secondary outcomes (1)
Percent change in fasting TG
Percent change in fasting TG from baseline to Day 15, 30, 60, 90, 135, 225, and 270
Measured: From baseline to Day 15, 30, 60, 90, 135, 225, and 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start28 Feb 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed DyslipidemiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuqiong Li, Master, Study director, Shanghai Argo Biopharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497127
- Sponsor's protocol ID
- BW-00112-2002
- Status last verified
- Jan 2026
- First submitted
- 4 Jul 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Subcutaneously Administered BW-00112 in Patients With Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT06497127
- Acronym / sponsor ID
- BW-00112-2002
- Conditions
- Mixed Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 11 Jul 2024 (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.
A Phase 2 in Patients With Mixed Dyslipidemia
Detailed description
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Subcutaneously Administered BW-00112 in Patients with Mixed Dyslipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BW-00112BW-00112 150 mg or volume-matched placebo on Day 1 and Day 90 |
| Cohort 2 | Experimental | Drug: BW-00112BW-00112 300 mg or volume-matched placebo on Day 1 and Day 90 |
| Cohort 3 | Experimental | Drug: BW-00112BW-00112 600 mg or volume-matched placebo on Day 1 and Day 90 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have given written informed consent and be able to comply with all study requirements.
- Males or females aged 18 to 75 aged years, inclusive, at the time of informed consent
- Fasting LDL-C ≥ 70 mg/dL [1.8 mmol/L] at Screening.
- 4.150 mg/dL [1.7 mmol/L] ≤ fasting TG < 500 mg/dL [5.6 mmol/L] at Screening, which may be repeated once if deemed necessary.
- 5.On a stable statin for at least 1 month before Screening and plan to remain on the same medication and dose for the duration of the study.
Key exclusion criteria (5 listed)
- Active pancreatitis within 12 weeks prior to Day 1.
- Clinically significant acute cardiovascular even or procedure
- HbA1c > 9.0% at Screening or patients with diabetes who have experienced diabetic ketoacidosis, diabetic decompensation, hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks prior to Day 1.
- Presence of any clinically significant uncontrolled disease known to influence serum lipids or lipoproteins. NOTE: Patients on thyroid replacement therapy are eligible if the dosage of thyroxine has been stable for at least 12 weeks prior to Day 1.
- Use of TG lowering medication , non-prescription dietary supplements or other cholesterol lowering medication 30 days prior to Day 1, other than statins and ezetimibe.
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 |
|---|---|---|
| BW-00112BW-00112 or volume-matched placebo on Day 1 and Day 90 | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Percent change in fasting TG
Time frame: From baseline to Day 180
Percent change in fasting TG from baseline to Day 180
1 secondary outcome
Percent change in fasting TG
Time frame: From baseline to Day 15, 30, 60, 90, 135, 225, and 270
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 13 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Mixed Dyslipidemia
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Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
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A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
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Not yet recruitingPhase 3
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
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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.
Yuqiong Li, Master study director
Shanghai Argo Biopharmaceutical Co., Ltd.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BW-00112 in people with Mixed Dyslipidemia, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 14 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
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?
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 fasting TG (time frame: From baseline to Day 180). 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 13 Jan 2026.