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NASHPhase 1/2NCT06491576

A Clinical Trial of BGT-002 Tablets in Subjects With Nonalcoholic Steatohepatitis

A Phase 1/2 study testing BGT-002 in people with NASH, run by Burgeon Therapeutics Co., Ltd. at 1 site in China.

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 study is a single-center, randomized, double-blind, multiple ascending doses (MAD), placebo-controlled phase Ib/IIa clinical trial of BGT-002 Tablets in subjects with NASH to evaluate the safety, tolerability, pharmacokinetics (PK) and early pharmacodynamics (PD) of BGT-002 Tablets. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
NASH
What is being tested?
BGT-002
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteChina
Study dates
21 Mar 2023to 4 Mar 2024
Phase
Phase 1/2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects aged ≥ 18 and ≤ 65, male or female;
  • Body mass index (BMI) ≥ 25 kg/m^2 at screening;
  • Subjects fulfilling the following criteria:
  • ALT level exceeds the upper limit of normal once within 3 months (ALT elevation without other obvious reasons);
  • Mean liver fat content ≥ 10% during screening and at the end of the run-in period (MRI-PDFF);
  • Stable body weight (defined as weight gain or loss ≤ 5%) 4-8 weeks pre-dose;
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  • Pre-dose blood pressure: Systolic blood pressure ≤ 160 mmHg and diastolic blood pressure ≤ 95 mmHg (oral antihypertensive drugs can be taken regularly);
  • Maintain the same medication and lifestyle (diet and/or exercise) as those at enrollment during the trial;
  • Subjects who have no birth plan from screening to 6 months after the last dose and voluntarily take reliable contraceptive measures;
  • Subjects who fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial, and sign the written ICF, and are able to complete all trial processes according to the trial requirements.

Who cannot join

  • Subjects with a known history of allergies to the test product, any of its components, or related products; as well as those with allergic diseases or an allergic constitution;
  • Subjects with heavy alcohol consumption for 3 consecutive months or above within 1 year before screening. "Heavy alcohol consumption" is defined as average daily alcohol consumption of > 20 g for females and > 30 g for males, or uncontrollable alcohol consumption;
  • Subjects with cirrhosis suggested by liver biopsy or clinically diagnosed cirrhosis;
  • Subjects with other concomitant liver diseases, including but not limited to drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, hemochromatosis, Wilson's disease, suspected or confirmed liver cancer;
  • Subjects who have received liver transplantation surgery or plan to have this surgery:
  • Subjects who have received bariatric surgery or plan to have this surgery during the study;
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  • Subjects with type 1 diabetes and poorly controlled type 2 diabetes (HbA1c > 10.5% at screening);
  • Patients with diabetes who use hypoglycemic drugs other than metformin;
  • Subjects with a history of malignant tumor within 5 years before screening (Note: 1. Subjects with cervical carcinoma in situ whose lesions have been resected and with no evidence of recurrence or metastasis for at least 3 years may participate in this study. 2. Subjects with basal cell or squamous cell carcinoma whose lesions have been completely resected and with no recurrent lesions for at least 3 years can participate in this study;
  • Subjects with serious cardiovascular and cerebrovascular events within 6 months before screening, including but not limited to uncontrolled or serious arrhythmia (ventricular fibrillation, atrial fibrillation, etc.), angina unstable, acute myocardial infarction, cardiac failure congestive, coronary intervention (including coronary artery stent implantation, intracoronary thrombectomy, and percutaneous transluminal coronary angioplasty, etc) or coronary artery bypass surgery, peripheral vascular intervention, stroke (except lacunar infarction), and transient ischaemic attack;
  • Subjects with gastrointestinal diseases or postoperative conditions affecting drug absorption;
  • Subjects who are taking drugs that may cause steatosis/steatohepatitis;
  • Subjects who have used ACLY-targeted drugs (Nexletol, etc.) and other study drugs, are taking statins (lovastatin, simvastatin, pravastatin, mevastatin, fluvastatin, atorvastatin, cerivastatin, rosuvastatin, pitavastatin, etc.), fibric acids (such as fenofibrate, gemfibrozil), probucol, warfarin, systemic steroids, cyclosporin or other immunosuppressants, or have taken these drugs less than 1 month or 5 half-lives of the drug (whichever is longer) from the first administration of the study drug;
  • Subjects who have used drugs with potential therapeutic effects on NASH (such as GLP-1 receptor agonists, DPP4 inhibitors, SGLT2 inhibitors, or other drugs known to affect liver function and cause steatosis at the discretion of the investigator) during the trial period and within less than 1 month from the screening;
  • Subjects with a TG > 6.0 mmol/L, direct bilirubin > 2 × ULN, creatinine clearance < 60 mL/min (calculated using the Cockcroft-Gault formula);
  • Platelet count < 75 × 10^9/L;
  • Subjects with confirmed positive and clinically significant results for antinuclear antibody (ANA) at screening;
  • Subjects with a history of hypothyroidism, hyperthyroidism, or subclinical thyroid disease (except for those with TSH levels < 10 mu/l, normal free T3 and T4 levels, and no symptoms of hypothyroidism);
  • Subjects with contraindications to MRI scan;
  • Subjects with blood donation or blood loss ≥ 400 mL within 3 months before screening;
  • Subjects who have participated in other drug clinical trials within 1 month prior to the screening;
  • Pregnant/lactating women or subjects confirmed positive in serum pregnancy test (female);
  • Subjects with positive results in urinary drug screening (morphine, marijuana);
  • Subjects who have consumed any food or beverage containing alcohol (or positive alcohol breath test result), grapefruit juice/grapefruit juice, methylxanthine (such as coffee, tea, cola, chocolate, and energy drink) within 1 day pre-dose, or have strenuous exercise or other factors affecting drug absorption, distribution, metabolism, and excretion;
  • Subjects with other severe systemic diseases unrelated to NASH;
  • Subjects infected with viral hepatitis (including hepatitis B and C), AIDS, or syphilis;
  • Subjects with high-risk factors of torsades de pointes (hypokalemia, hypomagnesemia, heart rate < 45 bpm), and ECG QTc interval longer than 490 ms during screening;
  • Subjects with other factors deemed by investigators as not suitable for the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130031

Other trials in China

About this study

Official title: A Single-center, Randomized, Double-blind, Multiple Ascending Dose, Placebo-controlled Phase Ib/IIa Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of BGT-002 Tablets in Subjects With NASH

This study is a single-center, randomized, double-blind, multiple ascending doses (MAD), placebo-controlled phase Ib/IIa clinical trial of BGT-002 Tablets in subjects with NASH to evaluate the safety, tolerability, pharmacokinetics (PK) and early pharmacodynamics (PD) of BGT-002 Tablets.

Conditions
NASH
Being tested
BGT-002, Placebo

What participants receive

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

  • BGT-002Drug

    taking the study drug orally

  • PlaceboDrug

    taking the placebo orally

Study groups in NCT06491576
Study groupRoleWhat they receive
Test GroupExperimentalNot described
Receives: Drug: BGT-002
Placebo GroupPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Number of participants with adverse events

    Measured: From Day 1 to Day 56

  2. C-QTc(Concentration-QTc)

    To investigate the effect of BGT-002 on QT/QTc interval in subjects

    Measured: Day1、Day28

Secondary outcomes (18)

  1. Cmax(Peak Concentration)

    The peak concentration of BGT-002 tablets was assessed after oral administration of BGT-002

    Measured: Day1

  2. Tmax(Time of maximum observed concentration)

    Evaluate the time required for the drug to reach its maximum concentration after oral administration of BGT-002

    Measured: Day1

  3. AUC(0-24h)(Area Under Curve)

    The area under the curve was assessed 0 to 24 hours after oral administration of BGT-002

    Measured: Day1

  4. Cmax,ss

    The peak concentration at stable state was assessed after oral administration of BGT-002

    Measured: Day28

  5. Tmax,ss

    The peak time at stable state was assessed after oral administration of BGT-002

    Measured: Day28

  6. AUCss

    The area under the curve at stable state after the subject's oral administration of BGT-002 was assessed

    Measured: Day28

  7. CLss/F(Steady-State Clearance/bioavailability,F)

    The clearance rate at stalbe state was assessed after oral administration of BGT-002

    Measured: Day28

  8. Cmin,ss

    Assess valley concentrations at stable state after oral administration of BGT-002

    Measured: Day28

  9. Rac(Accumulation Ratio)

    Assess the drug accumulation index after oral administration of BGT-002

    Measured: Day28

  10. MRI-PDFF(Magnetic resonance imaging-derived proton density fat fraction)

    Assess the changes of magnetic resonance imaging derived proton density fat fraction after oral administration of BGT-002

    Measured: Day1 (for subjects with results within 7 days pre-dose, examination may be omitted on Day1), Day29/early withdrawal (+5 days), and Day56 (± 5 days)

  11. CAP(controlled attenuation parameter)

    Assess the changes of controlled attenuation parameter based on ultrasound after oral administration of BGT-002

    Measured: Day1 (for subjects with results within 7 days pre-dose, examination may be omitted on Day1), Day29/early withdrawal (+5 days), and Day56 (± 5 days)y29、Day56

  12. LSM(Liver Stiffness Measuremen)

    Assess the changes of liver stiffness measurement after oral administration of BGT-002

    Measured: Day1 (for subjects with results within 7 days pre-dose, examination may be omitted on Day1), Day29/early withdrawal (+5 days), and Day56 (± 5 days)

  13. BMI(Body Mass Index)

    Changes of Body Mass Index were assessed after oral administration of BGT-002

    Measured: Day1, Day29/early withdrawal, and Day56 (± 5 days)

  14. ALT(Alanine Aminotransferase)

    Changes of Alanine Aminotransferase were assessed after oral administration of BGT-002

    Measured: Day1, Day29/early withdrawal, and Day56 (± 5 days)

  15. ASTc(Aspartate Transaminase)

    Changes of Aspartate Transaminase were assessed after oral administration of BGT-002

    Measured: Day1, Day29/early withdrawal, and Day56 (± 5 days)

  16. TG(Triglyceride)

    Changes of Triglyceride were assessed after oral administration of BGT-002

    Measured: Day1, Day29/early withdrawal, and Day56 (± 5 days)

  17. LDL-C(Low-Density Lipoprotein Cholesterol)

    Changes of Low-Density Lipoprotein Cholesterol were assessed after oral administration of BGT-002

    Measured: Day1, Day29/early withdrawal, and Day56 (± 5 days)

  18. TC(total cholesterol)

    Changes of serum total cholesterol were assessed after oral administration of BGT-002

    Measured: Day1, Day29/early withdrawal, and Day56 (± 5 days)

Timeline

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

  1. First posted9 Jul 2024
  2. Study start21 Mar 2023
  3. Primary completion4 Mar 2024
  4. Study completion4 Mar 2024

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06491576
Sponsor's protocol ID
BGT-002-004
Status last verified
Jun 2024
First submitted
30 May 2024
Last updated
9 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BGT-002 in people with NASH, run by Burgeon Therapeutics 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 10 inclusion and 28 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 9 Jul 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 combined 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.

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?

Number of participants with adverse events (time frame: From Day 1 to Day 56). The study lists 2 primary outcomes in all. 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 NCT06491576.

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 9 Jul 2024.

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