HealthyPhase 1NCT06309667
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.
A Phase 1 study testing PG-102(MG12) in people with Healthy and Overweight, run by ProGen. Co., Ltd. at 1 site in South Korea.
Trial summary
This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight
- What is being tested?
- PG-102(MG12)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2024to 5 Feb 2025
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent
- Body mass index (BMI) of 18 to 30kg/m2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B and Body mass index (BMI) 30 kg/m² or higher for Part C
- [Exclusion Criteria]
- History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and/or other foods within 90 days prior to screening:
- Drugs that affect body weight (such as obesity medications, psychiatric drugs, beta blockers, diuretics, contraceptives, female hormones, proton-pump inhibitors (PPIs), H2 receptor antagonists, health functional foods/supplements, and formulas designed for weight control).
- Drugs that have the potential to impact blood sugar, liver fat, and intestinal microorganisms (including GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones (TZDs), fish oil, polyunsaturated fatty acids (PUFA), and ursodeoxycholic acid (UDCA)), as well as individuals who are currently using insulin.
Show all 9Show fewer
- History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.
- History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.
- History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding etc) or gastrointestinal procedures for weight loss (including LAP-BAND®), or uncontrolled gastrointestinal disorders at Screening (e.g., peptic ulcer, gastroesophageal reflux disease).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Catholic University Seoul St.Mary Hospital,
Seocho, Seoul, 06591
About this study
Official title: A Double-blind, Randomized, Placebo Controlled, Combined Single (Part A) and Multiple (Part B, C) Ascending Dose, Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetic and Pharmacodynamics Following Subcutaneous Injections of PG-102(MG12) in Healthy Adult and Obesity Participants
This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.
This study will be conducted in 3 Parts (Part A, B and C), with up to 5 cohorts in each part.
Read the detailed description
Part A (SAD):
In Part A, subjects will receive a single dose of study drug, and the safety and efficacy of PG-102(MG12) will be evaluated in healthy subjects.
Part B (MAD):
In Part B, subjects will receive once-weekly doses of the study drug for 4 weeks, and the safety and efficacy of PG-102(MG12) will be evaluated in otherwise healthy overweight adult subjects.
Part C (MAD):
In Part C, obese participants will receive five repeated subcutaneous doses of the study drug, and the safety and tolerability of PG-102 (MG12) will be assessed across two cohorts based on prior safety data from Part B.
- Conditions
- Healthy, Overweight
- Being tested
- PG-102(MG12), Placebo
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG-102(MG12)Drug
GLP-1 and GLP-2 fusion protein
PlaceboOther
Placebo drug of PG-102(MG12)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 - Single Ascending Dose | Experimental | PG-102(MG12) Dose 1 (N=8) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
| Cohort A2 - Single Ascending Dose | Experimental | PG-102(MG12) Dose 2 (N=8) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
| Cohort A3 - Single Ascending Dose | Experimental | PG-102(MG12) Dose 3 (N=8) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
| Cohort A4 - Single Ascending Dose | Experimental | PG-102(MG12) Dose 4 (N=8) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
| Cohort A5 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 5 (N=8) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
| Cohort B1 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 1 (N=6) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
| Cohort B2 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 1~5 (N=6) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
| Cohort B3 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 1~5 (N=6) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
| Cohort S - Multiple Ascending Dose | Experimental | PG-102(MG12) Optimal Dose (N=6) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
| Cohort C1 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 1 (N=12) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
| Cohort C2 - Multiple Ascending Dose | Experimental | PG-102(MG12) Dose 1 (N=12) Subcutaneous injection Receives: Drug: PG-102(MG12); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs) for Part A
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Baseline to Day 29
Number of participants with treatment-emergent adverse events (TEAEs) for Part B
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Baseline to Day 57
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Measured: Baseline to Day 29
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Measured: Baseline to Day 57
Number of participants with clinically significant abnormalities in vital signs for Part A
Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Measured: Baseline to Day 29
Number of participants with clinically significant abnormalities in vital signs for Part B
Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Measured: Baseline to Day 57
Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
Measured: Baseline to Day 29
Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
Measured: Baseline to Day 57
Secondary outcomes (10)
Maximum plasma concentration (Cmax) for Part A
Maximum plasma concentration (Cmax)
Measured: Baseline to Day 29
Maximum plasma concentration (Cmax) for Part B
Maximum plasma concentration (Cmax)
Measured: Baseline to Day 57
Time to maximum plasma concentration (tmax) for Part A
Time to maximum plasma concentration (tmax)
Measured: Baseline to Day 29
Time to maximum plasma concentration (tmax) for Part B
Time to maximum plasma concentration (tmax)
Measured: Baseline to Day 57
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)
Measured: Baseline to Day 29
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)
Measured: Baseline to Day 57
Terminal half-life (t1/2) for Part A
Terminal half-life (t1/2)
Measured: Baseline to Day 29
Terminal half-life (t1/2) for Part B
Terminal half-life (t1/2)
Measured: Baseline to Day 57
Apparent total clearance (CL/F) for Part A
Apparent total clearance (CL/F)
Measured: Baseline to Day 29
Apparent total clearance (CL/F) for Part B
Apparent total clearance (CL/F)
Measured: Baseline to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start4 Mar 2024
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
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 HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProGen. Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seunghoon Han, MD, Principal investigator, Catholic University Seoul St.Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309667
- Sponsor's protocol ID
- SL-MG12-P1
- Status last verified
- May 2025
- First submitted
- 14 Feb 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang SI, Kim SW, Son KH, Lee SA, Kim JG, Roh JI, Sung YC. Bispecific GLP-1/GLP-2 agonism in advanced type 2 diabetes: preclinical characterization and a randomized, double-blind, placebo-controlled phase I trial. Nat Commun. 2026 Mar 24;17(1):4477. doi: 10.1038/s41467-026-71080-0.
PubMed 41876542
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo Controlled, Combined Single (Part A) and Multiple (Part B, C) Ascending Dose, Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetic and Pharmacodynamics Following Subcutaneous Injections of PG-102(MG12) in Healthy Adult and Obesity Participants
- ClinicalTrials.gov ID
- NCT06309667
- Acronym / sponsor ID
- SL-MG12-P1
- Conditions
- Healthy, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- ProGen. Co., Ltd.University, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.
This study will be conducted in 3 Parts (Part A, B and C), with up to 5 cohorts in each part.
Detailed description
Part A (SAD):
In Part A, subjects will receive a single dose of study drug, and the safety and efficacy of PG-102(MG12) will be evaluated in healthy subjects.
Part B (MAD):
In Part B, subjects will receive once-weekly doses of the study drug for 4 weeks, and the safety and efficacy of PG-102(MG12) will be evaluated in otherwise healthy overweight adult subjects.
Part C (MAD):
In Part C, obese participants will receive five repeated subcutaneous doses of the study drug, and the safety and tolerability of PG-102 (MG12) will be assessed across two cohorts based on prior safety data from Part B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 - Single Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Dose 1 (N=8) Subcutaneous injection |
| Cohort A2 - Single Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Dose 2 (N=8) Subcutaneous injection |
| Cohort A3 - Single Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Dose 3 (N=8) Subcutaneous injection |
| Cohort A4 - Single Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Dose 4 (N=8) Subcutaneous injection |
| Cohort A5 - Multiple Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Dose 5 (N=8) Subcutaneous injection |
| Cohort B1 - Multiple Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Dose 1 (N=6) Subcutaneous injection |
| Cohort B2 - Multiple Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Dose 1~5 (N=6) Subcutaneous injection |
| Cohort B3 - Multiple Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Dose 1~5 (N=6) Subcutaneous injection |
| Cohort S - Multiple Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Optimal Dose (N=6) Subcutaneous injection |
| Cohort C1 - Multiple Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Dose 1 (N=12) Subcutaneous injection |
| Cohort C2 - Multiple Ascending Dose | Experimental | Drug: PG-102(MG12), Other: PlaceboPG-102(MG12) Dose 1 (N=12) Subcutaneous injection |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent
- Body mass index (BMI) of 18 to 30kg/m2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B and Body mass index (BMI) 30 kg/m² or higher for Part C
- [Exclusion Criteria]
- History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and/or other foods within 90 days prior to screening:
- History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PG-102(MG12)GLP-1 and GLP-2 fusion protein | Drug | Cohort A1 - Single Ascending Dose, Cohort A2 - Single Ascending Dose, Cohort A3 - Single Ascending Dose, Cohort A4 - Single Ascending Dose, Cohort A5 - Multiple Ascending Dose, Cohort B1 - Multiple Ascending Dose, Cohort B2 - Multiple Ascending Dose, Cohort B3 - Multiple Ascending Dose, Cohort C1 - Multiple Ascending Dose, Cohort C2 - Multiple Ascending Dose, Cohort S - Multiple Ascending Dose |
| PlaceboPlacebo drug of PG-102(MG12) | Other | Cohort A1 - Single Ascending Dose, Cohort A2 - Single Ascending Dose, Cohort A3 - Single Ascending Dose, Cohort A4 - Single Ascending Dose, Cohort A5 - Multiple Ascending Dose, Cohort B1 - Multiple Ascending Dose, Cohort B2 - Multiple Ascending Dose, Cohort B3 - Multiple Ascending Dose, Cohort C1 - Multiple Ascending Dose, Cohort C2 - Multiple Ascending Dose, Cohort S - Multiple Ascending Dose |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs) for Part A
Time frame: Baseline to Day 29
Number of participants with treatment-emergent adverse events (TEAEs)
Number of participants with treatment-emergent adverse events (TEAEs) for Part B
Time frame: Baseline to Day 57
Number of participants with treatment-emergent adverse events (TEAEs)
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A
Time frame: Baseline to Day 29
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B
Time frame: Baseline to Day 57
Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0
Number of participants with clinically significant abnormalities in vital signs for Part A
Time frame: Baseline to Day 29
Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Number of participants with clinically significant abnormalities in vital signs for Part B
Time frame: Baseline to Day 57
Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)
Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A
Time frame: Baseline to Day 29
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B
Time frame: Baseline to Day 57
Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)
10 secondary outcomes
Maximum plasma concentration (Cmax) for Part A
Time frame: Baseline to Day 29
Maximum plasma concentration (Cmax) for Part B
Time frame: Baseline to Day 57
Time to maximum plasma concentration (tmax) for Part A
Time frame: Baseline to Day 29
Time to maximum plasma concentration (tmax) for Part B
Time frame: Baseline to Day 57
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A
Time frame: Baseline to Day 29
Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B
Time frame: Baseline to Day 57
Terminal half-life (t1/2) for Part A
Time frame: Baseline to Day 29
Terminal half-life (t1/2) for Part B
Time frame: Baseline to Day 57
Apparent total clearance (CL/F) for Part A
Time frame: Baseline to Day 29
Apparent total clearance (CL/F) for Part B
Time frame: Baseline to Day 57
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 6 May 2025.
- Derived from this study: PubMed 41876542Yang SI, Kim SW, Son KH, Lee SA, Kim JG, Roh JI, Sung YC. Bispecific GLP-1/GLP-2 agonism in advanced type 2 diabetes: preclinical characterization and a randomized, double-blind, placebo-controlled phase I trial. Nat Commun. 2026 Mar 24;17(1):4477. doi: 10.1038/s41467-026-71080-0.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Seunghoon Han, MD principal investigator
Catholic University Seoul St.Mary Hospital
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 PG-102(MG12) in people with Healthy and Overweight, run by ProGen. Co., Ltd. at 1 site in South Korea.
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 0 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 6 May 2025. 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 South Korea. 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?
Number of participants with treatment-emergent adverse events (TEAEs) for Part A (time frame: Baseline to Day 29). The study lists 8 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 NCT06309667, 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 6 May 2025.