Type 2 Diabetes Mellitus - Poor ControlPhase 3NCT07057271

A Study of CJC-1134-PC Injection in Patients With Type 2 Diabetes With Inadequately Controlled Blood Glucose Level After Metformin Monotherapy or Metformin in Combination With Insulin Secretagogues

A Phase 3 study testing CJC-1134-PC Injection in people with Type 2 Diabetes Mellitus - Poor Control, run by Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Designed to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once A Week in Patients with Type 2 Diabetes with Inadequately Controlled Blood Glucose Level after Metformin Monotherapy or Metformin in… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus - Poor Control
What is being tested?: CJC-1134-PC Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 464 participants
Where: 1 siteChina
Study dates: 27 May 2021to 21 Feb 2023
Phase: Phase 3
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects were eligible for the study only if all the following inclusion criteria were met:
Males or females aged 18 - 70 years (inclusive) at screening;
Subjects with body mass index (BMI) ≥ 20 kg/ m2 and ≤ 40 kg/ m2.
Patients with type 2 diabetes diagnosed according to the World Health Organization (WHO) 1999 criteria and who have received metformin monotherapy or metformin in combination with insulin secretagogues at stable doses for at least 2 consecutive months at screening (a daily dose of NLT 1,500 mg or a maximum tolerated dose and NLT 1,000 mg/day for metformin, and a dose of NLT half of the maximum dose as recommended in local IFU or the maximum tolerated dose for insulin secretagogues).
Patients with stable living habits 2 months prior to screening, e.g., stable dietary habits and physical activities;
Patients with the fasting plasma glucose or fasting serum glucose at the clinical site and the fasting plasma glucose in the central laboratory of NMT 13.9 mmol/L (250 mg/dL) at screening period; with the fasting plasma glucose in the central laboratory of NMT 13.9 mmol/L (250 mg/dL) at V3;
Patients with the HbA1c level of NLT 7.0% and NMT 11.0% at screening in local laboratory, and with the HbA1c level of NLT 7.0% and NMT 11.0% at screening and V3 in the central laboratory;
Patients who were able to understand the procedures and methods of the study, willing to strictly comply with the clinical trial protocol, and voluntarily signed the informed consent form.

Who cannot join

Diagnosis of type 1 diabetes mellitus, or a specific type of diabetes mellitus caused by damage to the pancreas or other disease (such as acromegaly or Cushing syndrome);
History of acute pancreatitis prior to screening or current history of acute or chronic pancreatitis.
Active gallbladder or biliary tract disease within 1 year prior to screening (active refers to the presence of associated symptoms);
Family or personal history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (family refers to first-degree relatives by blood);
Individuals with a history of malignant tumors within the previous 5 years, except patients with cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
Decompensated cardiac dysfunction (New York Heart Association cardiac class III or IV) within 6 months prior to screening or currently;

Show all 39Show fewer

Myocardial infarction, coronary artery bypass grafting, coronary stenting, hemorrhagic or ischemic stroke (except lacunar cerebral infarction), or hospitalization for unstable angina or transient ischemic attack within 6 months prior to screening;
Uncontrolled and severe cardiac dysrhythmia [e.g., second- or third-degree atrioventricular block, prolonged QT interval (QTc >450 ms)] within 6 months prior to screening and judged by the investigator to be unsuitable for participation in this trial;
Severe diabetic neuropathy within 6 months prior to screening;
History of diabetic foot ulcer within 1 year prior to screening;
Proliferative diabetic retinopathy within 6 months prior to screening or at the time of screening [confirmed by fundus photography without mydriasis or by fundus examination with medicated mydriasis (unless mydriasis is contraindicated) by an eye health care provider, or a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to screening];
Diabetic ketoacidosis or hyperglycemic hyperosmolar state occurred within 6 months before screening to before randomization;
History of 2 or more episodes of severe hypoglycemia within 6 months prior to screening or severe hypoglycemia between screening and pre-randomization (see Section 3.3.2.1 of version 1.2 of the protocol for definition of hypoglycemia);
Previous (e.g., major or total gastrectomy, sleeve gastrectomy, gastric bypass) or current history of significant gastrointestinal disease (e.g., active ulcers, gastroparesis, pyloric obstruction, intestinal obstruction, inflammatory bowel disease, etc.) or chronic gastrastric-related surgery disease that requires long-term use of medications directly affecting gastrointestinal peristalsis and judged by the investigator to be unsuitable to participate in this trial;
Severe trauma or moderate to major surgery within 1 month prior to screening and up to the time of randomization or the need for systemic use of anti-infective medications and, in the judgment of the investigator, the above conditions may affect glycemic control; Prohibited treatments and/or drugs
Currently using weight-loss drugs, or the patient's weight has changed significantly (change NLT 10%) within 3 months before screening;
Received treatment with glucose-lowering medications other than metformin or insulin secretagogue (including traditional Chinese medicine with glucose-lowering effects or glucose-lowering medications under clinical validation) within 3 months prior to screening;
Continuous use of insulin treatment for more than 2 weeks within 1 year before screening (the time for gestational diabetes mellitus receiving insulin treatment is not within this limit);
Prior treatment with a dipeptidyl peptidase 4 (DPP-4) inhibitor or glucose-dependent insulinotropic polypeptide (GIP) or glucagon-like peptide-1 (GLP-1) receptor agonist and discontinuation due to lack of safety and/or efficacy;
Received treatment with any other investigational product or device within 3 months prior to screening;
Received systemic glucocorticoids (other than inhaled or topical use) or growth hormone treatment within 3 months before screening;
Being on warfarin at the time of screening and unable to discontinue it for the duration of the study; Laboratory findings
Systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg after 5 minutes of sedentary rest at screening or on the day of randomization [if the above criteria are met, the test can be repeated 2 more times (each time more than 1 minute apart) and the average of the 3 tests will be taken and judged again by the above criteria];
Estimated glomerular filtration rate (eGFR) <60 mL/min or urine protein qualitative test NLT ++;
Alanine aminotransferase (ALT) or/and aspartate aminotransferase (AST) >2.5 × ULN (upper limit of normal range) or total bilirubin level >1.5 × ULN (upper limit of normal range);
Currently accompanied by thyroid dysfunction that cannot be controlled with a stable drug dose (referring to a stable dose for 4 weeks or more) or abnormalities of clinical meaningfulness in thyroid function test results (TSH, FT4, FT3) during screening;
Currently suffering from anemia (hemoglobin level in males <120 g/L, females <110 g/L)) or other conditions that interfere with HbA1c testing;
Fasting triglycerides >5.64 mmol/L (500 mg/dL);
Serum amylase or serum lipase >3 × ULN (upper limit of normal range);
Hepatitis B surface antigen positive, hepatitis C antibodies positive or HIV antibodies positive (weak positive is regarded as positive); Gender and reproductive status
Positive pregnancy test result at screening;
Pregnant or lactating female at enrollment;
Female subjects of childbearing potential or male subjects whose sexual partner is a female of childbearing potential who are unwilling to use effective, medically approved contraception (including condoms containing sperm-inactivated spermatozoa, vaginal septum, and oral or injectable contraceptives) during the study and for 3 months after discontinuation; Other criteria
Alcoholics [>2 units of alcohol per day and >14 units of alcohol per week (1 unit of alcohol consumption is equivalent to 150 mL of wine or 350 mL of beer or 50 mL of spirits)] or a drug abuse history;
Blood donation or transfusion NLT 400 mL within 3 months prior to screening;
Intellectual disability or severe mental illness affecting the signing of informed consent or adherence to the study protocol;
Known allergies to ebenatide, human albumin (the raw material for the ebenatide formulation), empagliflozin, or related excipients;
Known intolerance to ebenatide or empagliflozin;
Other circumstances that the investigator deems inappropriate for participation in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University People's Hospital
Beijing, Beijing Municipality, 100044

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Designed to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once A Week in Patients With Type 2 Diabetes With Inadequately Controlled Blood Glucose Level After Metformin Monotherapy or Metformin in Combination With Insulin Secretagogues

Conditions: Type 2 Diabetes Mellitus - Poor Control
Being tested: CJC-1134-PC Injection, Placebo

What participants receive

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

CJC-1134-PC InjectionDrug
Double-blind Treatment Period: 0.2ml (2mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52)
PlaceboDrug
Double-blind Treatment Period: 0.2ml (0mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52)

Study groups in NCT07057271
Study group	Role	What they receive
CJC-1134-PC	Experimental	Injection, 0.2ml/2mg (prefilled pen) Receives: Drug: CJC-1134-PC Injection
Placebo	Placebo comparator	Injection, 0.2ml/0mg (prefilled pen) Receives: Drug: Placebo

What is being measured

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

Change from baseline in HbA1c at the end of double-blind treatment period
The double-blind treatment period ended at the 25-week visit.
Measured: Week 25 visit

Secondary outcomes (19)

Proportion of subjects with HbA1c <7.0% at the end of the double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Proportion of subjects with HbA1c <6.5% at the end of the double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting weight at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting waist circumference at the end of double-blind /open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting plasma glucose at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting proinsulin at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting insulin at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting C-peptide at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (total cholesterol) at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (low-density lipoprotein [LDL]) at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (high-density lipoprotein [HDL]) at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (triglycerides) at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (LDL/HDL ratio) at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in systolic blood pressure [SBP] at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in diastolic blood pressure [DBP] at the end of double-blind treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in 6-point finger-stick blood glucose at the end of double-blind/open-label treatment period.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in blood AST at the end of double-blind/open-label treatment period in patients diagnosed with fatty liver on screening imaging.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Changes from baseline in blood ALT at the end of double-blind/open-label treatment period in patients diagnosed with fatty liver on screening imaging.
The double-blind treatment period ended at the 25-week visit, and the open-label treatment period ended at the 53-week visit.
Measured: Week 25 visit, and week 53 visit.
Change from baseline in HbA1c at the end of open-label treatment period.
The open-label treatment period ended at the 53-week visit.
Measured: Week 53 visit.

Timeline

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

27 May 202121 Feb 2023

First posted9 Jul 2025
Study start27 May 2021
Primary completion21 Feb 2023
Study completion21 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes Mellitus - Poor ControlStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 464 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07057271
Sponsor's protocol ID: CSCJC DM301
Status last verified: Jun 2025
First submitted: 30 Jun 2025
Last updated: 9 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus - Poor Control trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Designed to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once A Week in Patients With Type 2 Diabetes With Inadequately Controlled Blood Glucose Level After Metformin Monotherapy or Metformin in Combination With Insulin Secretagogues
ClinicalTrials.gov ID: NCT07057271
Acronym / sponsor ID: CSCJC DM301
Conditions: Type 2 Diabetes Mellitus - Poor Control
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 464 participants (actual)
Lead sponsor: Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 27 May 2021 (actual)
Primary completion: 21 Feb 2023 (actual)
Study completion: 21 Feb 2023 (actual)
First posted: 9 Jul 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CJC-1134-PC	Experimental	Drug: CJC-1134-PC InjectionInjection, 0.2ml/2mg (prefilled pen)
Placebo	Placebo comparator	Drug: PlaceboInjection, 0.2ml/0mg (prefilled pen)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subjects were eligible for the study only if all the following inclusion criteria were met:
Males or females aged 18 - 70 years (inclusive) at screening;
Subjects with body mass index (BMI) ≥ 20 kg/ m2 and ≤ 40 kg/ m2.
Patients with type 2 diabetes diagnosed according to the World Health Organization (WHO) 1999 criteria and who have received metformin monotherapy or metformin in combination with insulin secretagogues at stable doses for at least 2 consecutive months at screening (a daily dose of NLT 1,500 mg or a maximum tolerated dose and NLT 1,000 mg/day for metformin, and a dose of NLT half of the maximum dose as recommended in local IFU or the maximum tolerated dose for insulin secretagogues).
Patients with stable living habits 2 months prior to screening, e.g., stable dietary habits and physical activities;

Key exclusion criteria (39 listed)

Diagnosis of type 1 diabetes mellitus, or a specific type of diabetes mellitus caused by damage to the pancreas or other disease (such as acromegaly or Cushing syndrome);
History of acute pancreatitis prior to screening or current history of acute or chronic pancreatitis.
Active gallbladder or biliary tract disease within 1 year prior to screening (active refers to the presence of associated symptoms);
Family or personal history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (family refers to first-degree relatives by blood);
Individuals with a history of malignant tumors within the previous 5 years, except patients with cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;

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
CJC-1134-PC InjectionDouble-blind Treatment Period: 0.2ml (2mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52)	Drug	CJC-1134-PC
PlaceboDouble-blind Treatment Period: 0.2ml (0mg) once weekly ×24 weeks (Week 1 to Week 24); Open-label Treatment Period: 0.2ml (2mg) once weekly ×28 weeks (Week 25 to Week 52)	Drug	Placebo

Primary outcome

Change from baseline in HbA1c at the end of double-blind treatment period
Time frame: Week 25 visit
The double-blind treatment period ended at the 25-week visit.

19 secondary outcomes

Proportion of subjects with HbA1c <7.0% at the end of the double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Proportion of subjects with HbA1c <6.5% at the end of the double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting weight at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting waist circumference at the end of double-blind /open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting plasma glucose at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting proinsulin at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting insulin at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting C-peptide at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (total cholesterol) at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (low-density lipoprotein [LDL]) at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (high-density lipoprotein [HDL]) at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (triglycerides) at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in fasting lipids (LDL/HDL ratio) at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in systolic blood pressure [SBP] at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in diastolic blood pressure [DBP] at the end of double-blind treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in 6-point finger-stick blood glucose at the end of double-blind/open-label treatment period.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in blood AST at the end of double-blind/open-label treatment period in patients diagnosed with fatty liver on screening imaging.
Time frame: Week 25 visit, and week 53 visit.
Changes from baseline in blood ALT at the end of double-blind/open-label treatment period in patients diagnosed with fatty liver on screening imaging.
Time frame: Week 25 visit, and week 53 visit.
Change from baseline in HbA1c at the end of open-label treatment period.
Time frame: Week 53 visit.

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 9 Jul 2025.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes Mellitus - Poor Control

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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, Prof. study chair

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?

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 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change from baseline in HbA1c at the end of double-blind treatment period (time frame: Week 25 visit). 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 NCT07057271.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.