Type 2 Diabetes MellitusPhase 2NCT05348122
A Study of TG103 Injection in Type 2 Diabetes Subjects
A Phase 2 study testing TG103,Q2W, TG103,QW and Dulaglutide,QW in people with Type 2 Diabetes Mellitus, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this trial is to evaluate the efficacy of different doses and frequencies of administration of TG103 injection in the treatment of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- TG103,Q2W, TG103,QW and Dulaglutide,QW
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2022to 1 Nov 2023
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 2 diabetes ;
- Aged 18 to 75 years (inclusive), no gender limitation;
- Body Mass Index (BMI): 18.5≤BMI≤40;
- Poor blood glucose control after diet and exercise alone without hypoglycemic drug treatment. Not treated with hypoglycemic drugs is defined as:Have not received hypoglycemic drugs before screening, or have received hypoglycemic drugs before screening, but have not received hypoglycemic drugs within 8 weeks before screening; and continuous use of insulin for no more than 14 days (except gestational diabetes) and/or the continuous use of another hypoglycemic drug for no more than 4 weeks within 1 year prior to screening;
- HbA1c must meet the following criteria:Screening: 7.5% ≤ HbA1c ≤ 11.0% (Local laboratory);Baseline: 7.0% ≤ HbA1c ≤ 10.5% (Central laboratory)
- Subjects of childbearing potential must use reliable methods of contraception throughout the study period and at least 3 months after the last dose to avoid pregnancy in female subjects or pregnancy in the male subject's partner;
- Must be able to accurately use home glucose meter for self-glucose monitoring;
- Be able to understand and follow the trial procedure, voluntarily participate in the trial and sign the informed consent form.
Who cannot join
- Type 1 diabetes;
- Body weight change more than 5% within 1 month prior to screening;
- Receive any of the following medications:Prior discontinuation of DPP-4 inhibitors or GLP-1 receptor agonists for efficacy, tolerability, and safety reasons;Systemic glucocorticoid and growth hormone have been used within 8 weeks before screening or before randomization;
- History of grade 3 hypoglycemia ≥2 times within 6 months prior to screening, or grade 3 hypoglycemia prior to screening to randomization;
- Acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemia, occurred ≥1 time within 6 months prior to screening, or prior to randomization;
- Severe chronic complications of diabetes (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening
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- History of acute or chronic pancreatitis prior to screening, or acute or chronic pancreatitis prior to randomization;
- Subjects with clinically significant gastric emptying abnormalities (e.g., gastric outlet obstruction), severe chronic gastrointestinal diseases (e.g., gastroparesis, inflammatory bowel disease, or intestinal obstruction) within 6 months prior to screening, or prior to randomization, long-term use of drugs that directly affect gastrointestinal motility, or gastrointestinal surgery that affects gastric emptying;
- Any of the following cardiovascular events within 6 months prior to screening, or prior to randomization: unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, coronary stent implantation, moderate or severe congestive heart failure (NYHA grade III or IV), atrial or ventricular arrhythmia (e.g., atrial fibrillation, ventricular tachycardia, etc.), pacemaker or defibrillator implantation; Or subjects with Ⅱ or Ⅲ degree atrioventricular block, long QT syndrome or prolonged QTcF interval (QTcF: male >450 ms, female >470 ms) on 12-lead ECG, or signs of heart disease with significant clinical symptoms at screening;
- Hemorrhagic stroke or acute ischemic stroke disease occurred within 6 months prior to screening, or prior to randomization;
- Having a history of serious respiratory tract, central nervous system (such as epilepsy, etc.) and psychiatric diseases (such as depression, anxiety, etc.) during screening; Or have a history of other diseases that may endanger the safety of the subject and that the investigator deems inappropriate for enrollment;
- Any type of malignant tumor treated or untreated within 5 years prior to screening or prior to randomization (except clinically cured basal cell carcinoma or carcinoma in situ);
- Severe or acute infection within 4 weeks prior to screening, or refractory urinary tract or genital infection within 6 months prior to screening;
- Having a significant blood system disease (e.g., aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or red blood cell instability (e.g., malaria) at screening or prior to randomization;
- Subjects with thyroid dysfunction that cannot be controlled by a stable drug dose at screening, or with clinically significant abnormalities in thyroid function examination results requiring drug treatment at screening ;
- Personal or family history of medullary thyroid cancer (MTC) or type 2 multiple endocrine tumor syndrome at screening;
- Systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg at screening or before randomization;
- Any of the following abnormalities during screening or prior to randomization of laboratory tests:FPG≥13.9 mmol/L;ALT or AST≥2.5×ULN;Total bilirubin (TBiL) ≥1.5×ULN;Triglyceride >5.7 mmol/L;eGFR<60 mL/(min*1.73 m^2);Serum amylase and/or lipase ≥3×ULN (if lipase cannot be detected in some centers, amylase alone is acceptable);Hemoglobin <100 g/L;Calcitonin≥50 ng/L(pg/mL);
- Serological examination:Human immunodeficiency virus antibody or treponema pallidum antibody is positive;Hepatitis C antibody is positive;Hepatitis B surface antigen is positive, and the quantitative detection result of HBV DNA was higher than the lower limit of the detection reference range;
- Known allergy to the test drug, Empagliflozin , or related excipients;
- Subjects who underwent major surgery within 3 months prior to screening, or who lost more than 400 mL blood due to blood donation or other reasons within 3 months prior to screening;
- Average alcohol intake more than 21 units of alcohol (male)/14 units of alcohol (female) per week within the 3 months prior to screening (1 unit ≈360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine);
- Subject participated in any drug or medical device clinical study within 3 months prior to screening (except for screening failure);
- Pregnant or lactating female;
- Not suitable for this study in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
China1 site
Gao Huanhuan
Shijiazhuang, Hebei, 050035
Huanhuan Gao, +86-18031190343, lcgaohuanhuan@mail.ecspc.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled，Dulaglutide-controlled Phase Ⅱ Trial Exploring Optimal Dosing Regimen for TG103 Injection Monotherapy in Type 2 Diabetes
The primary objective of this trial is to evaluate the efficacy of different doses and frequencies of administration of TG103 injection in the treatment of type 2 diabetes.
Read the detailed description
This trial is a randomized, double-blind, placebo-parallel, Dulaglutide-controlled，multicenter phase Ⅱ clinical trial. The whole trial consists of two parts, Part A and Part B, and 240 subjects are planned to be enrolled. Part A will be divided into three groups: TG103 15 mg group, TG103 22.5 mg group and placebo group, given once every two weeks (Q2W); Part B will be divided into four groups: TG103 7.5mg dose group, TG103 15 mg dose group ,placebo group and Dulaglutide group, once a week (QW). After Part A enrollment is completed, Part B will continue to be enrolled. The trial will include a screening period of up to 2 weeks, an initiation period of 2 weeks, a double-blind treatment period of 16 weeks, and a safety follow-up period of 3 weeks.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- TG103,Q2W, TG103,QW, Placebo,Q2W, Placebo,QW, Dulaglutide,QW
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG103,Q2WDrug
Also called TG103 injection, subcutaneous injection,Q2W
TG103 injection will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.
TG103,QWDrug
Also called TG103 injection, subcutaneous injection,QW
TG103 injection will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.
Placebo,Q2WDrug
Also called Placebo, subcutaneous injection,Q2W
Placebo will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.
Placebo,QWDrug
Also called Placebo, subcutaneous injection,QW
Placebo will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.
Dulaglutide,QWDrug
Also called Dulaglutide,subcutaneous injection,QW
Dulaglutide will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| TG103, 15 mg,Q2W | Experimental | TG103 (15 mg) will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes. Receives: Drug: TG103,Q2W |
| TG103, 22.5 mg,Q2W | Experimental | TG103 (22.5 mg) will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes. Receives: Drug: TG103,Q2W |
| Placebo,Q2W | Placebo comparator | Placebo will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes. Receives: Drug: Placebo,Q2W |
| TG103, 7.5 mg,QW | Experimental | TG103 (7.5 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. Receives: Drug: TG103,QW |
| TG103, 15 mg,QW | Experimental | TG103 (15 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. Receives: Drug: TG103,QW |
| Placebo,QW | Placebo comparator | Placebo will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. Receives: Drug: Placebo,QW |
| Dulaglutide,QW | Active comparator | Dulaglutide will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. Receives: Drug: Dulaglutide,QW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17
Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17
Measured: Baseline through Day 113
Secondary outcomes (11)
Changes in glycosylated hemoglobin (HbA1c) from baseline to week 9
Changes in glycosylated hemoglobin (HbA1c) from baseline to week 9
Measured: Baseline through Day57
The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7% at week 9 and 17
The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7% at week 9 and 17
Measured: Day57 and 113
Change in fasting plasma glucose (FPG) from baseline to week 9 and 17
Change in fasting plasma glucose (FPG) from baseline to week 9 and 17
Measured: Baseline through Day57 and 113
Change in weight from baseline to week 9 and 17
Change in weight from baseline to week 9 and 17
Measured: Baseline through Day57 and 113
Mean postprandial blood glucose increment and change in mean postprandial blood glucose from baseline at 7-point Self-monitored Blood Glucose (SMBG) Profile.
Mean postprandial blood glucose increment and change in mean postprandial blood glucose from baseline at 7-point Self-monitored Blood Glucose (SMBG) Profile.
Measured: Baseline through Day113
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile.
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile.
Measured: Baseline through Day113
Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from baseline to week 17.
Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from baseline to week 17.
Measured: Baseline through Day113
Proportion of subjects receiving remedial therapy at week 17
Proportion of subjects receiving remedial therapy at week 17
Measured: Day113
Number of TEAEs and SAEs from baseline to week 17
Number of TEAEs and SAEs from baseline to week 17
Measured: Day-14 through Day 113
Ctrough will be measured once every 4 week until week 17
Ctrough will be measured once every 4 week until week 17
Measured: Day1, 29, 57, 85 and 113
The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (Nab).
The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (Nab).
Measured: Day1, 29, 57, 85, 113 and127
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start15 Jun 2022 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linong Ji, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348122
- Sponsor's protocol ID
- SYSA1803-008
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled，Dulaglutide-controlled Phase Ⅱ Trial Exploring Optimal Dosing Regimen for TG103 Injection Monotherapy in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05348122
- Acronym / sponsor ID
- SYSA1803-008
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 27 Apr 2022 (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 trial is to evaluate the efficacy of different doses and frequencies of administration of TG103 injection in the treatment of type 2 diabetes.
Detailed description
This trial is a randomized, double-blind, placebo-parallel, Dulaglutide-controlled，multicenter phase Ⅱ clinical trial. The whole trial consists of two parts, Part A and Part B, and 240 subjects are planned to be enrolled. Part A will be divided into three groups: TG103 15 mg group, TG103 22.5 mg group and placebo group, given once every two weeks (Q2W); Part B will be divided into four groups: TG103 7.5mg dose group, TG103 15 mg dose group ,placebo group and Dulaglutide group, once a week (QW). After Part A enrollment is completed, Part B will continue to be enrolled. The trial will include a screening period of up to 2 weeks, an initiation period of 2 weeks, a double-blind treatment period of 16 weeks, and a safety follow-up period of 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| TG103, 15 mg,Q2W | Experimental | Drug: TG103,Q2WTG103 (15 mg) will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes. |
| TG103, 22.5 mg,Q2W | Experimental | Drug: TG103,Q2WTG103 (22.5 mg) will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes. |
| Placebo,Q2W | Placebo comparator | Drug: Placebo,Q2WPlacebo will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes. |
| TG103, 7.5 mg,QW | Experimental | Drug: TG103,QWTG103 (7.5 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. |
| TG103, 15 mg,QW | Experimental | Drug: TG103,QWTG103 (15 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. |
| Placebo,QW | Placebo comparator | Drug: Placebo,QWPlacebo will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. |
| Dulaglutide,QW | Active comparator | Drug: Dulaglutide,QWDulaglutide will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of type 2 diabetes ;
- Aged 18 to 75 years (inclusive), no gender limitation;
- Body Mass Index (BMI): 18.5≤BMI≤40;
- Poor blood glucose control after diet and exercise alone without hypoglycemic drug treatment. Not treated with hypoglycemic drugs is defined as:Have not received hypoglycemic drugs before screening, or have received hypoglycemic drugs before screening, but have not received hypoglycemic drugs within 8 weeks before screening; and continuous use of insulin for no more than 14 days (except gestational diabetes) and/or the continuous use of another hypoglycemic drug for no more than 4 weeks within 1 year prior to screening;
- HbA1c must meet the following criteria:Screening: 7.5% ≤ HbA1c ≤ 11.0% (Local laboratory);Baseline: 7.0% ≤ HbA1c ≤ 10.5% (Central laboratory)
Key exclusion criteria (25 listed)
- Type 1 diabetes;
- Body weight change more than 5% within 1 month prior to screening;
- Receive any of the following medications:Prior discontinuation of DPP-4 inhibitors or GLP-1 receptor agonists for efficacy, tolerability, and safety reasons;Systemic glucocorticoid and growth hormone have been used within 8 weeks before screening or before randomization;
- History of grade 3 hypoglycemia ≥2 times within 6 months prior to screening, or grade 3 hypoglycemia prior to screening to randomization;
- Acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemia, occurred ≥1 time within 6 months prior to screening, or prior to randomization;
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 |
|---|---|---|
| TG103,Q2WAlso: TG103 injection, subcutaneous injection,Q2WTG103 injection will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes. | Drug | TG103, 15 mg,Q2W, TG103, 22.5 mg,Q2W |
| TG103,QWAlso: TG103 injection, subcutaneous injection,QWTG103 injection will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. | Drug | TG103, 15 mg,QW, TG103, 7.5 mg,QW |
| Placebo,Q2WAlso: Placebo, subcutaneous injection,Q2WPlacebo will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes. | Drug | Placebo,Q2W |
| Placebo,QWAlso: Placebo, subcutaneous injection,QWPlacebo will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. | Drug | Placebo,QW |
| Dulaglutide,QWAlso: Dulaglutide,subcutaneous injection,QWDulaglutide will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes. | Drug | Dulaglutide,QW |
Primary outcome
Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17
Time frame: Baseline through Day 113
Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17
11 secondary outcomes
Changes in glycosylated hemoglobin (HbA1c) from baseline to week 9
Time frame: Baseline through Day57
The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7% at week 9 and 17
Time frame: Day57 and 113
Change in fasting plasma glucose (FPG) from baseline to week 9 and 17
Time frame: Baseline through Day57 and 113
Change in weight from baseline to week 9 and 17
Time frame: Baseline through Day57 and 113
Mean postprandial blood glucose increment and change in mean postprandial blood glucose from baseline at 7-point Self-monitored Blood Glucose (SMBG) Profile.
Time frame: Baseline through Day113
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile.
Time frame: Baseline through Day113
Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from baseline to week 17.
Time frame: Baseline through Day113
Proportion of subjects receiving remedial therapy at week 17
Time frame: Day113
Number of TEAEs and SAEs from baseline to week 17
Time frame: Day-14 through Day 113
Ctrough will be measured once every 4 week until week 17
Time frame: Day1, 29, 57, 85 and 113
The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (Nab).
Time frame: Day1, 29, 57, 85, 113 and127
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Linong Ji principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TG103,Q2W, TG103,QW and Dulaglutide,QW in people with Type 2 Diabetes Mellitus, run by CSPC Baike (Shandong) Biopharmaceutical 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 8 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 13 Jun 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huanhuan Gao (+86-8031190343, lcgaohuanhuan@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17 (time frame: Baseline through Day 113). 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 Jun 2022.