Obesity / OverweightPhase 1NCT07794111
A Clinical Trial of TQF6422 Injection in Overweight or Obese Healthy Subjects.
A Phase 1 study testing TQF6422 Injection in people with Obesity / Overweight, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 1 site in China.
Trial summary
This is a placebo-controlled, double-blind trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of TQF6422 Injection in overweight or obese healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity / Overweight
- What is being tested?
- TQF6422 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Jun 2028
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese male or female trial participants aged ≥18 years (inclusive) and ≤55 years (inclusive).
- Participant body weight ≥50 kg, with body-mass index (BMI) of 24-40 kg/m² (end-points included).
- At screening, the following findings shall be within normal limits, or deemed clinically insignificant by the Investigator despite being abnormal and not meeting exclusion criteria: vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray, abdominal ultrasound, and clinical laboratory tests (including but not limited to hematology, urinalysis, serum biochemistry, coagulation function, serological virology, and thyroid function).
- Negative human immunodeficiency virus antibody (HIV-Ab) test.
- For female participants:
- Non-childbearing potential: including surgical sterilization performed at least 6 weeks prior to screening visit (documented tubal ligation, hysterectomy, or bilateral oophorectomy), or post-menopausal status for ≥12 months prior to screening visit (confirmed by follicle-stimulating hormone (FSH) level ≥40 IU/L); OR
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- Child-bearing potential: must be non-pregnant and non-lactating, and must agree to use effective (at least one highly-effective) non-pharmacological contraceptive measures from 14 days before screening, throughout the study period, and for 6 months after study drug administration. Serum pregnancy test shall be negative with human chorionic gonadotropin (hCG) <5 mIU/mL at screening and baseline (D-1). Participants shall not donate ova during this period.
- Male participants with female partners of child-bearing potential must agree to use effective (at least one highly-effective) non-pharmacological contraceptive measures from 14 days before screening, throughout the study period, and for 6 months after study drug administration. Male participants shall not donate sperm during this period.
- Voluntarily provide written informed consent prior to trial participation, with full understanding of trial content, procedures and potential adverse reactions; able to communicate adequately with the Investigator, and understand and comply with all study-related requirements.
Who cannot join
- Participants meeting any of the following criteria will be excluded from enrollment:
- Presence of clinically-significant ongoing disease, or history of chronic/severe disease, including but not limited to circulatory, lymphatic, respiratory, endocrine, urinary, digestive, nervous, psychiatric, or infectious diseases, malignant neoplasms, severe trauma; or other conditions judged by the Investigator to be exclusionary or likely to confound interpretation of trial results.
- History of second-degree or higher cardiac conduction block, or PR interval >220 ms; risk factors or history of torsades de pointes ventricular tachycardia, including but not limited to unexplained syncope, long-QT syndrome, heart failure; OR any abnormal 12-lead ECG at screening judged by the Investigator to increase risks associated with study participation.
- History of gastrointestinal surgery causing malabsorption (except for endoscopic resections such as gastric polypectomy), or long-term use of medications directly affecting gastrointestinal motility.
- Use within 3 months prior to screening, or ongoing use of medications known to significantly affect body weight (regardless of therapeutic indication), including: GLP-1R agonists, GLP-1R/GIPR agonists, GLP-1R/GCGR agonists, systemic corticosteroids (intravenous, oral or intra-articular), metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, thiazolidinediones (TZDs), tricyclic antidepressants, psychotropic or sedative agents (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, lithium salts).
- Known comorbid diseases affecting the skeletal-muscle system (e.g., myasthenia gravis, muscular dystrophy); or use of any medications or supplements known to affect muscle anabolism/catabolism within 3 months prior to screening.
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- Sunburn, scar tissue, tattoos covering >25 % of total body surface area, open ulcers or branding at screening, judged by the Investigator to interfere with interpretation of cutaneous adverse reactions.
- Clinically-significant infection at screening, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, herpes zoster, requiring antibiotic or antiviral therapy.
- Receipt of live-virus vaccine within 4 weeks prior to randomization, or planned live-virus vaccination during the study.
- Surgical procedure performed within 4 weeks prior to randomization, or planned surgery during the study.
- Blood transfusion, blood loss or blood donation exceeding 400 mL within 3 months prior to screening (excluding physiological menstrual blood loss in female subjects), and/or platelet donation within 2 weeks prior to study drug administration.
- Use of any prescription, over-the-counter, or herbal medicines within 4 weeks prior to randomization (if 5-half-lives of the relevant drug exceed 14 days, the 5-half-life period shall apply).
- History of needle-phobia or venipuncture-related vasovagal syncope, difficult-to-access venipuncture, or intolerance to venous puncture.
- Known hypersensitivity to any component of TQF6422 injection, or prior history of severe allergic reactions (including any food or drug allergy).
- History of substance abuse within 3 months prior to screening, or positive urine drug screen.
- Cigarette smoking >10 cigarettes per day, or equivalent nicotine-containing product use within 3 months prior to screening; or inability to abstain from all tobacco-containing products during the study.
- Chronic alcohol abuse, or alcohol intake exceeding 14 units per week within 3 months prior to screening (1 unit = 360 mL beer, or 45 mL 40 %-proof spirit, or 150 mL wine); or inability to refrain from alcohol during the study; or positive alcohol breath test.
- Habitual excessive intake of caffeine-containing beverages or food within 4 weeks prior to randomization (e.g., coffee, tea, milk-tea, chocolate, cola, energy drinks). Daily caffeine intake shall not exceed 6 units. 1 caffeine-unit = 1 cup coffee (177.4 mL) = 2 cans cola (354.9 mL) = 1 cup tea (354.9 mL) = ½ can energy drink = 85 g chocolate.
- Consumption of grapefruit, Seville-orange or their juices within 7 days prior to first-dose, or inability to discontinue consumption of grapefruit, Seville-orange or their juices during the study.
- Special-dietary requirements that prevent adherence to standard-diet instructions.
- Participation in any investigational drug or medical-device clinical trial within 3 months prior to screening, or planned participation in another clinical trial during this study.
- Body-weight change >5 % within 3 months prior to screening.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or treponema pallidum antibody (TP-Ab).
- Meeting any of the following clinical laboratory criteria at screening:
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.0×ULN, and/or total bilirubin (TBIL) >1.2×ULN;
- Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula <90 mL/min/1.73 m²;
- Serum creatine kinase (CK) >1.2×ULN;
- Serum amylase or lipase >1.0×ULN.
- Any other condition or factor judged by the Investigator rendering the subject unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Xuening Li, Master, 86-21-31587862, li.xuening@zs-hospital.sh.cn
About this study
Official title: A Phase 1 Clinical Trial of TQF6422 Injection to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles Following Single and Multiple Ascending Doses in Healthy Overweight or Obese Subjects.
This is a placebo-controlled, double-blind trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of TQF6422 Injection in overweight or obese healthy participants.
- Conditions
- Obesity / Overweight
- Being tested
- TQF6422 Injection, TQF6422 Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQF6422 InjectionDrug
TQF6422 injection is an anti-ActRIIA/IIB monoclonal antibody.
TQF6422 PlaceboDrug
A placebo matching TQF6422 Injection in appearance, dosage form, and route of administration, but containing no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Part A: TQF6422 Injection (Single Dose) | Experimental | Participants in this arm will receive a single dose of TQF6422 Injection. Receives: Drug: TQF6422 Injection |
| Part A: TQF6422 Placebo (Single Dose) | Placebo comparator | Participants in this arm will receive a single dose of placebo matching TQF6422 Injection. Receives: Drug: TQF6422 Placebo |
| Part B: TQF6422 Injection (Once Weekly) | Experimental | Participants in this arm will receive TQF6422 Injection administered once weekly (QW) for multiple doses. Receives: Drug: TQF6422 Injection |
| Part B: TQF6422 Injection (Once Every 4 Weeks) | Experimental | Participants in this arm will receive TQF6422 Injection administered once every 4 weeks (Q4W) for multiple doses. Receives: Drug: TQF6422 Injection |
| Part B: TQF6422 Placebo (Once Weekly or Once Every 4 Weeks) | Placebo comparator | Participants in this arm will receive placebo matching TQF6422 Injection administered Once Weekly or Once Every 4 Weeks. Receives: Drug: TQF6422 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to day84 in part A and day112 in part B.
Secondary outcomes (16)
Time-to-maximum concentration( Tmax)
Time-to-maximum concentration of TQF6422
Measured: Predose to Day 84 after administration in part A ;Predose to Day 112 after administration in part B.
Peak concentration (Cmax)
Maximum plasma drug concentration of TQF6422
Measured: Predose to Day 84 after administration in part A ;Predose to Day 112 after administration in part B.
Area under the concentration-time curve(AUC)
Area under the plasma concentration-time curve of TQF6422
Measured: Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B.
Apparent volume of distribution (Vd/F)
Apparent Volume of Distribution at the Terminal Phase divided by Bioavailability.
Measured: Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B.
Apparent Clearance (CL/F)
The apparent volume of plasma from which the drug is completely removed per unit time, adjusted for bioavailability
Measured: Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B.
Plasma half life (t1/2)
The time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half of TQF6422
Measured: Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B.
Change from baseline and percentage change from baseline in total body weight
Body weight will be measured with shoes and headwear removed.
Measured: at Week 4, Week 8, and Week 12 following the last administration.
Change from baseline and percentage change from baseline in waist circumference
Waist circumference should be measured in the horizontal plane, at the midpoint between the inferior margin of the last palpable rib and the top of the iliac crest.
Measured: at Week 4, Week 8, and Week 12 following the last administration.
Change from baseline in total fat mass (TFM)
Change from baseline in the TFM will be measured by dual-energy X-ray absorptiometry (DXA) after the last dose
Measured: at Week 4, Week 8, and Week 12 following the last administration.
Change from baseline in total lean body mass (LBM)
Change from baseline in the LBM will be measured by dual-energy X-ray absorptiometry (DXA) after the last dose
Measured: at Week 4, Week 8, and Week 12 following the last administration.
Myostatin and Activin A levels
Determine the changes in serum Myostatin and Activin A levels from baseline at each visit.
Measured: Up to day 84 after administration in part A;Up to day 112 after administration in part B.
Fasting plasma glucose
Changes and percentage changes in fasting plasma glucose after administration.
Measured: Up to day 84 after administration in part A;Up to day 112 after administration in part B.
Fasting insulin
Changes and percentage changes in fasting insulin after administration.
Measured: Up to day 84 after administration in part A;Up to day 112 after administration in part B.
Glycated hemoglobin (HbA1c)
Changes and percentage changes in HbA1c after administration.
Measured: Up to day 84 after administration in part A;Up to day 112 after administration in part B.
Lipid parameters
Changes and percentage changes in Lipid parameters after administration.
Measured: Up to day 84 after administration in part A;Up to day 112 after administration in part B.
Anti-drug antibody (ADA) levels
Test ADA status in biological sample via validated methodology.
Measured: Predose to Day 84 after administration in part A ；Predose to Day 112 after administration in part B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity / OverweightStudies of the same condition, open and under way.
- More trials run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.The sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794111
- Sponsor's protocol ID
- TQF6422-1-01
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial of TQF6422 Injection to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles Following Single and Multiple Ascending Doses in Healthy Overweight or Obese Subjects.
- ClinicalTrials.gov ID
- NCT07794111
- Acronym / sponsor ID
- TQF6422-1-01
- Conditions
- Obesity / Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 31 Aug 2026 (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 placebo-controlled, double-blind trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of TQF6422 Injection in overweight or obese healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: TQF6422 Injection (Single Dose) | Experimental | Drug: TQF6422 InjectionParticipants in this arm will receive a single dose of TQF6422 Injection. |
| Part A: TQF6422 Placebo (Single Dose) | Placebo comparator | Drug: TQF6422 PlaceboParticipants in this arm will receive a single dose of placebo matching TQF6422 Injection. |
| Part B: TQF6422 Injection (Once Weekly) | Experimental | Drug: TQF6422 InjectionParticipants in this arm will receive TQF6422 Injection administered once weekly (QW) for multiple doses. |
| Part B: TQF6422 Injection (Once Every 4 Weeks) | Experimental | Drug: TQF6422 InjectionParticipants in this arm will receive TQF6422 Injection administered once every 4 weeks (Q4W) for multiple doses. |
| Part B: TQF6422 Placebo (Once Weekly or Once Every 4 Weeks) | Placebo comparator | Drug: TQF6422 PlaceboParticipants in this arm will receive placebo matching TQF6422 Injection administered Once Weekly or Once Every 4 Weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Chinese male or female trial participants aged ≥18 years (inclusive) and ≤55 years (inclusive).
- Participant body weight ≥50 kg, with body-mass index (BMI) of 24-40 kg/m² (end-points included).
- At screening, the following findings shall be within normal limits, or deemed clinically insignificant by the Investigator despite being abnormal and not meeting exclusion criteria: vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray, abdominal ultrasound, and clinical laboratory tests (including but not limited to hematology, urinalysis, serum biochemistry, coagulation function, serological virology, and thyroid function).
- Negative human immunodeficiency virus antibody (HIV-Ab) test.
- For female participants:
Key exclusion criteria (29 listed)
- Presence of clinically-significant ongoing disease, or history of chronic/severe disease, including but not limited to circulatory, lymphatic, respiratory, endocrine, urinary, digestive, nervous, psychiatric, or infectious diseases, malignant neoplasms, severe trauma; or other conditions judged by the Investigator to be exclusionary or likely to confound interpretation of trial results.
- History of second-degree or higher cardiac conduction block, or PR interval >220 ms; risk factors or history of torsades de pointes ventricular tachycardia, including but not limited to unexplained syncope, long-QT syndrome, heart failure; OR any abnormal 12-lead ECG at screening judged by the Investigator to increase risks associated with study participation.
- History of gastrointestinal surgery causing malabsorption (except for endoscopic resections such as gastric polypectomy), or long-term use of medications directly affecting gastrointestinal motility.
- Use within 3 months prior to screening, or ongoing use of medications known to significantly affect body weight (regardless of therapeutic indication), including: GLP-1R agonists, GLP-1R/GIPR agonists, GLP-1R/GCGR agonists, systemic corticosteroids (intravenous, oral or intra-articular), metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, thiazolidinediones (TZDs), tricyclic antidepressants, psychotropic or sedative agents (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, lithium salts).
- Known comorbid diseases affecting the skeletal-muscle system (e.g., myasthenia gravis, muscular dystrophy); or use of any medications or supplements known to affect muscle anabolism/catabolism within 3 months prior to screening.
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 |
|---|---|---|
| TQF6422 InjectionTQF6422 injection is an anti-ActRIIA/IIB monoclonal antibody. | Drug | Part A: TQF6422 Injection (Single Dose), Part B: TQF6422 Injection (Once Every 4 Weeks), Part B: TQF6422 Injection (Once Weekly) |
| TQF6422 PlaceboA placebo matching TQF6422 Injection in appearance, dosage form, and route of administration, but containing no active ingredient. | Drug | Part A: TQF6422 Placebo (Single Dose), Part B: TQF6422 Placebo (Once Weekly or Once Every 4 Weeks) |
Primary outcome
Adverse event rate
Time frame: Baseline up to day84 in part A and day112 in part B.
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
16 secondary outcomes
Time-to-maximum concentration( Tmax)
Time frame: Predose to Day 84 after administration in part A ;Predose to Day 112 after administration in part B.
Peak concentration (Cmax)
Time frame: Predose to Day 84 after administration in part A ;Predose to Day 112 after administration in part B.
Area under the concentration-time curve(AUC)
Time frame: Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B.
Apparent volume of distribution (Vd/F)
Time frame: Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B.
Apparent Clearance (CL/F)
Time frame: Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B.
Plasma half life (t1/2)
Time frame: Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B.
Change from baseline and percentage change from baseline in total body weight
Time frame: at Week 4, Week 8, and Week 12 following the last administration.
Change from baseline and percentage change from baseline in waist circumference
Time frame: at Week 4, Week 8, and Week 12 following the last administration.
Change from baseline in total fat mass (TFM)
Time frame: at Week 4, Week 8, and Week 12 following the last administration.
Change from baseline in total lean body mass (LBM)
Time frame: at Week 4, Week 8, and Week 12 following the last administration.
Myostatin and Activin A levels
Time frame: Up to day 84 after administration in part A;Up to day 112 after administration in part B.
Fasting plasma glucose
Time frame: Up to day 84 after administration in part A;Up to day 112 after administration in part B.
Fasting insulin
Time frame: Up to day 84 after administration in part A;Up to day 112 after administration in part B.
Glycated hemoglobin (HbA1c)
Time frame: Up to day 84 after administration in part A;Up to day 112 after administration in part B.
Lipid parameters
Time frame: Up to day 84 after administration in part A;Up to day 112 after administration in part B.
Anti-drug antibody (ADA) levels
Time frame: Predose to Day 84 after administration in part A ；Predose to Day 112 after administration in part B.
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 31 Aug 2026.
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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.
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 TQF6422 Injection in people with Obesity / Overweight, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development 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 9 inclusion and 29 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: opening soon, as of the sponsor's last update on 31 Aug 2026. 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?
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 Xuening Li, Master (86-21-31587862, li.xuening@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event rate (time frame: Baseline up to day84 in part A and day112 in part B.). 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 31 Aug 2026.