Type 2 Diabetes MellitusPhase 1NCT05146869
A Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients
A Phase 1 study testing DBPR108 tablets in people with Type 2 Diabetes Mellitus, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose and multiple-dose of DBPR108 tablets in Type 2 Diabetes Mellitus Patients. 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?
- DBPR108 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2021to 28 Mar 2022
- Phase
- Phase 1
- 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
- Patients who meet the World Health Organization (WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes mellitus;
- 18 ≤ age ≤ 75 years old, male or female;
- Body mass index (BMI) within the range of 19-35 kg/m^2 (inclusive), BMI = weight (kg) / height^2 (m^2);
- 7.0% ≤Hemoglobin A1c (HbA1c) ≤ 9.5%;
- Patients who voluntarily participate in the study and sign the informed consent form;
- Patients who agree to use contraception from the signing of the informed consent form until 1 month after the end of the last medication.
Who cannot join
- Fasting plasma glucose (FPG) > 13.9 mmol/L;
- The investigator determines that the patients need to use insulin therapy;
- Patients with acute or serious complications of diabetes (including diabetic ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);
- History of severe hypoglycemia (hypoglycemia with severe cognitive impairment and requiring other measures to help recover);
- History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);
- History of allergy to DPP-4 inhibitors or the investigator determines that the patients may be allergic to investigational drug;
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- Patients with untreated hyperthyroidism and other diseases, which may affect blood glucose;
- Patients who have used other hypoglycemic drugs within 14 days before the first dose; or patients who are not suitable for this study as determined by the investigator due to taking other hypoglycemic drugs;
- Patients with inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders;
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 3 * upper limit of normal (ULN), or total bilirubin > 1.5 *ULN;
- Abnormal renal function: serum creatinine>1.5 * ULN; or eGFR< 45 mL/min/1.73m^2;
- White blood cells (WBC) < 3.0 *10^9/L and neutrophil count of peripheral blood < 1.5 * 10^9/L; hemoglobin < 100 g / L; triglyceride > 5.7 mmol/L;
- Patients who have the second or third degree atrioventricular block, long Q-T syndrome, or QTc>500 ms without cardiac pacemaker;
- Patients with any one of HBsAg, hepatitis C antibody, anti-HIV antibody and antibody of treponema pallidum positive;
- Female patients of childbearing age with pregnant test positive or lactating women;
- History of alcohol or drug abuse within 3 months before screening, alcohol abuse is average alcohol intake more than 14 units alcohol (1 unit=12 ounces or 360 mL of beer,1.5 ounces or 45 mL spirits with 40% alc/vol, 5 ounces or 150 mL grape wine); or intake any other products containing alcohol within 2 days before the first administration of investigational product;
- Patients who smoke more than 5 cigarettes per day within 3 months prior to screening;
- Patients with consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) within 2 days before the first administration in treatment period , or patients who have strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, etc;
- Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening;
- Patients with the following diseases:
- Serious dysrhythmias, obvious left ventricular dysfunction, New York Heart Association (NYHA) functional class III or IV;
- History of unstable angina pectoris, myocardial infarction, or other high-risk coronary artery diseases;
- Uncontrolled hypertension, systolic pressure ≥160 mmHg or diastolic pressure ≥100 mmHg;
- History of cancer , organ transplantation;
- History of epilepsy, psychosis, severe depression, etc.
- Not suitable for this study as determined by the investigator due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
About this study
Official title: A Randomized, Open-Label, Parallel-Cohort, Single-dose and Multiple-dose Phase I Study of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients
This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose and multiple-dose of DBPR108 tablets in Type 2 Diabetes Mellitus Patients.
Read the detailed description
This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, single-dose and multiple-dose of DBPR108 tablets in Chinese Type 2 Diabetes Mellitus Patients. The 30 eligible patients will be randomized to receive 50 mg, 100 mg, or 200 mg DBPR108 tablets.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DBPR108 tablets
- 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.
DBPR108 tabletsDrug
DBPR108 tablets, oral, once daily on Day 1 and Day 3-9 for a total of 8 doses.
| Study group | Role | What they receive |
|---|---|---|
| 50 mg DBPR108 tablets | Experimental | 10 patients will be randomized to receive 50 mg DBPR108 tablets. Receives: Drug: DBPR108 tablets |
| 100 mg DBPR108 tablets | Experimental | 10 patients will be randomized to receive 100 mg DBPR108 tablets. Receives: Drug: DBPR108 tablets |
| 200 mg DBPR108 tablets | Experimental | 10 patients will be randomized to receive 200 mg DBPR108 tablets. Receives: Drug: DBPR108 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of DBPR108 tablets
Cmax of DBPR108 tablets will be assessed after single-dose and multiple-dose administration
Measured: Day 1-Day 11
Area under the plasma concentration versus time curve (AUC) of DBPR108 tablets in plasma
AUC of DBPR108 tablets will be assessed after single-dose and multiple-dose administration
Measured: Day 1-Day 11
Half-life(t1/2) of DBPR108 tablets
T1/2 of DBPR108 tablets will be assessed after single-dose and multiple-dose administration
Measured: Day 1-Day 11
Apparent volume of Distribution(Vz/F)of DBPR108 tablets
Vz/F of DBPR108 tablets will be assessed after single-dose and multiple-dose administration
Measured: Day 1-Day 11
CL/F of DBPR108 tablets
Apparent clearance(CL/F) of DBPR108 tablets will be assessed single-dose and multiple-dose administration
Measured: Day 1-Day 11
Change from baseline in dipeptidyl peptidase-IV inhibition rate
Change from baseline in dipeptidyl peptidase-IV inhibition rate will be assessed after single-dose and multiple-dose administration
Measured: Day 1-Day 11
Change from baseline in active glucagon-like peptide1 concentration
Change from baseline in active glucagon-like peptide1 concentration will be assessed after single-dose and multiple-dose administration
Measured: Day 1-Day 11
Secondary outcomes (13)
The number of patients with adverse events
The number of patients with adverse events as a measure of safety and tolerability.
Measured: Throughout the study period, with an average of 1 months
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point
ECG monitoring includes P-R, QT and QTc intervals in ms.
Measured: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11).
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Vital signs monitoring includes respiratory rate and pulse in times per minute
Measured: Throughout the study period, with an average of 1 months
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Vital signs monitoring includes systolic blood pressure and diastolic blood pressure in mmHg.
Measured: Throughout the study period, with an average of 1 months
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Vital signs monitoring includes body temperature in degrees Celsius
Measured: Throughout the study period, with an average of 1 months
Clinically significant changes from baseline in physical examination will be recorded as AEs at each visit time point.
Physical examination includes mucocutaneous, lymphonodus, head and neck,chest, abdomen, spinal column, musculoskeletal, nervous system
Measured: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11).
Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point.
Routine blood test includes white blood cell count, platelet, neutrophilic granulocyte count, lymphocyte count and monocyte count in 10^9 /L.
Measured: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point.
Blood biochemistry test includes total protein, albumin and albumin in g/L.
Measured: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point.
Blood biochemistry test includes alanine aminotransferase, aspartate aminotransferase, amylase, alkaline phosphatase and in U/L.
Measured: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point.
Blood biochemistry test includes ureophil, glucose, triglyceridein, total cholesterol, high-density lipoprotein, low-density lipoprotein, sodium, potassium, chlorine, calcium in mmol/L
Measured: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point.
Blood biochemistry test includes total bilirubin and serum creatinine in umol/L.
Measured: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day 11)
Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point.
Routine urine test includes the count of leukocyte, and red blood cell in high-power field.
Measured: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point.
Routine urine test includes glucose, protein, ketonein in negative or positive.
Measured: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start30 Dec 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang Lin, PhD, Principal investigator, Beijing Anzhen Hospital of Capital Medical University , Beijing, ChinaShan NA Jing, PhD, Principal investigator, Beijing Anzhen Hospital of Capital Medical University , Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146869
- Sponsor's protocol ID
- HA1118-014
- Status last verified
- Apr 2022
- First submitted
- 12 Nov 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu W, Yang K, Lin Y, Lu C, Liu J, Zhou H, Wang J, Zhang T, Yao L, Qi H, Zhang X, Jia R, Li X, Jing S. Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes. Clin Pharmacokinet. 2025 May;64(5):703-713. doi: 10.1007/s40262-025-01501-8. Epub 2025 Apr 19.
PubMed 40252162
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Cohort, Single-dose and Multiple-dose Phase I Study of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT05146869
- Acronym / sponsor ID
- HA1118-014
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 7 Dec 2021 (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 phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose and multiple-dose of DBPR108 tablets in Type 2 Diabetes Mellitus Patients.
Detailed description
This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, single-dose and multiple-dose of DBPR108 tablets in Chinese Type 2 Diabetes Mellitus Patients. The 30 eligible patients will be randomized to receive 50 mg, 100 mg, or 200 mg DBPR108 tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50 mg DBPR108 tablets | Experimental | Drug: DBPR108 tablets10 patients will be randomized to receive 50 mg DBPR108 tablets. |
| 100 mg DBPR108 tablets | Experimental | Drug: DBPR108 tablets10 patients will be randomized to receive 100 mg DBPR108 tablets. |
| 200 mg DBPR108 tablets | Experimental | Drug: DBPR108 tablets10 patients will be randomized to receive 200 mg DBPR108 tablets. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who meet the World Health Organization (WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes mellitus;
- 18 ≤ age ≤ 75 years old, male or female;
- Body mass index (BMI) within the range of 19-35 kg/m^2 (inclusive), BMI = weight (kg) / height^2 (m^2);
- 7.0% ≤Hemoglobin A1c (HbA1c) ≤ 9.5%;
- Patients who voluntarily participate in the study and sign the informed consent form;
Key exclusion criteria (26 listed)
- Fasting plasma glucose (FPG) > 13.9 mmol/L;
- The investigator determines that the patients need to use insulin therapy;
- Patients with acute or serious complications of diabetes (including diabetic ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);
- History of severe hypoglycemia (hypoglycemia with severe cognitive impairment and requiring other measures to help recover);
- History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);
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 |
|---|---|---|
| DBPR108 tabletsDBPR108 tablets, oral, once daily on Day 1 and Day 3-9 for a total of 8 doses. | Drug | 100 mg DBPR108 tablets, 200 mg DBPR108 tablets, 50 mg DBPR108 tablets |
Primary outcome
Peak plasma concentration (Cmax) of DBPR108 tablets
Time frame: Day 1-Day 11
Cmax of DBPR108 tablets will be assessed after single-dose and multiple-dose administration
Area under the plasma concentration versus time curve (AUC) of DBPR108 tablets in plasma
Time frame: Day 1-Day 11
AUC of DBPR108 tablets will be assessed after single-dose and multiple-dose administration
Half-life(t1/2) of DBPR108 tablets
Time frame: Day 1-Day 11
T1/2 of DBPR108 tablets will be assessed after single-dose and multiple-dose administration
Apparent volume of Distribution(Vz/F)of DBPR108 tablets
Time frame: Day 1-Day 11
Vz/F of DBPR108 tablets will be assessed after single-dose and multiple-dose administration
CL/F of DBPR108 tablets
Time frame: Day 1-Day 11
Apparent clearance(CL/F) of DBPR108 tablets will be assessed single-dose and multiple-dose administration
Change from baseline in dipeptidyl peptidase-IV inhibition rate
Time frame: Day 1-Day 11
Change from baseline in dipeptidyl peptidase-IV inhibition rate will be assessed after single-dose and multiple-dose administration
Change from baseline in active glucagon-like peptide1 concentration
Time frame: Day 1-Day 11
Change from baseline in active glucagon-like peptide1 concentration will be assessed after single-dose and multiple-dose administration
13 secondary outcomes
The number of patients with adverse events
Time frame: Throughout the study period, with an average of 1 months
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point
Time frame: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11).
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 1 months
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 1 months
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Time frame: Throughout the study period, with an average of 1 months
Clinically significant changes from baseline in physical examination will be recorded as AEs at each visit time point.
Time frame: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11).
Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point.
Time frame: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point.
Time frame: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point.
Time frame: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point.
Time frame: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.recorded as AEs at each visit time point.
Time frame: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day 11)
Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point.
Time frame: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point.
Time frame: Within screening period (Day-21 to Day-15), baseline period (Day-7 to Day-1), and before discharge (Day11)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 40252162Liu W, Yang K, Lin Y, Lu C, Liu J, Zhou H, Wang J, Zhang T, Yao L, Qi H, Zhang X, Jia R, Li X, Jing S. Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes. Clin Pharmacokinet. 2025 May;64(5):703-713. doi: 10.1007/s40262-025-01501-8. Epub 2025 Apr 19.
- 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.
Yang Lin, PhD principal investigator
Beijing Anzhen Hospital of Capital Medical University , Beijing, China
Shan NA Jing, PhD principal investigator
Beijing Anzhen Hospital of Capital Medical University , Beijing, China
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 DBPR108 tablets in people with Type 2 Diabetes Mellitus, run by CSPC ZhongQi Pharmaceutical Technology 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 6 inclusion and 26 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 5 Apr 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. 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?
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?
Peak plasma concentration (Cmax) of DBPR108 tablets (time frame: Day 1-Day 11). The study lists 7 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 NCT05146869, which also lists 1 linked publication.
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 5 Apr 2022.