Diabete Type 2Phase 1BRIDGE-BRNCT07518121
A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil
A Phase 1 study testing Efsubaglutide Alfa Injection in people with Diabete Type 2, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 1 site in Brazil.
Trial summary
This is a Phase I, randomized, double-blind, placebo-controlled, single-dose study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Efsubaglutide Alfa Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2026to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female adults, aged 18-45 years (both inclusive) at the time of signing the informed consent form (ICF).
- Body mass index (BMI) between 18-28 kg/m2 (both inclusive). Male participants must weigh no less than 50 kg, and female participants must weigh no less than 45 kg.
- Voluntary participation in this study, as documented by the written signature of two copies of the ICF.
- Negative serum pregnancy test for women of childbearing potential (WOCBP) during screening period. WOCBP and fertile male participants with WOCBP partners must use highly effective contraception methods without planning to become pregnant or to donate sperm or eggs throughout this study (from signing the ICF to at least 3 months after completion of this study).
- Be able to maintain good communication with the investigators and comply with all requirements of protocol to complete all trial procedures.
Who cannot join
- Known or suspected allergy to the investigational medicinal product, its components or drugs of the same class, or a clinically significant drug allergy, or a history of atopic allergic disease.
- Previously or currently diagnosed diabetes mellitus (T1D or T2D) or prediabetes, according to the diagnostic criteria of the Brazilian Diabetes Society (SBD) guideline, defined by any of the following laboratory findings:
- FPG ≥126 mg/dL or ≥7.0 mmol/L ;
- FPG 100-125 mg/dL or 5.6 -6.9 mmol/L (prediabetes);
- HbA1c ≥ 6.5% or ≥48 mmol/mol;
- HbA1c 5.7-6.4% or 39-47 mmol/mol (prediabetes).
Show all 22Show fewer
- History of clinically significant endocrine disorders that may affect glucose metabolism, body weight, or drug PK, including but not limited to Cushing's syndrome; acromegaly; pheochromocytoma; untreated or uncontrolled thyroid disorders (hyperthyroidism or hypothyroidism); polycystic ovary syndrome (PCOS) with metabolic abnormalities; adrenal insufficiency or other adrenal disorders; pituitary disorders affecting hormonal regulation.
- History of acute or chronic pancreatitis, symptomatic gallbladder disease (those who have recovered from cholecystectomy and have no sequelae after treatment are allowable to be enrolled), pancreatic injury or other high-risk factors that may lead to pancreatitis, or screening serum amylase or lipase >2X upper limit of normal (ULN).
- History of significant gastrointestinal (GI) disorders (e.g., gastroparesis, active ulcers within 6 months, or long-term use of medications that directly affect GI motility, or GI surgery within 6 months prior to screening.
- History or presence of hepatic, renal, cardiovascular, neurological, psychiatric, psychological or immunological disorders.
- Clinically significant abnormalities in physical examination, vital signs, laboratory tests, or 12-lead ECG at screening, and investigators consider that these abnormalities may affect participant's safety or study results. ECG abnormalities including but not limited to: second- or third-degree atrioventricular block; long QT syndrome or QTcF > 450 ms (males) or > 470 ms (females). (If the QTcF > 450 ms (males) or > 470 ms (females), two additional ECG measurements should be repeated, and the mean of the three values should be used to determine the participant's eligibility.); left bundle branch block;Wolff-Parkinson-White syndrome; Or other clinically significant 12-lead ECG abnormalities requiring treatment.
- Use of any prescription or over-the-counter (OTC) medications, traditional Chinese medicine within 12 months prior to screening that may confound PK, PD, or safety assessments.
- Personal or family history of thyroid C-cell tumors including medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia type 2 (MEN2), or presence of hyperthyroidism or hypothyroidism that has not been controlled with a stable medication dose (defined as a stable dose for at least 3 months or longer).
- Positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBSAg) and HBV-deoxyribonucleric adic (DNA) ≥ lab-specific ULN (for those with positive result on HBsAg, HBV-DNA test will be performed), hepatitis C antibody (HCV-Ab) and HCV-ribonucleric acid (RNA), participant can be eligible at the discretion of the investigator if HCV-Ab positive and HCV RNA negative, or Treponema pallidum antibody (TP-Ab).
- Pregnant or breastfeeding women.
- Donation or loss of ≥400 mL of blood within 3 months prior to screening.
- History of drug abuse within 1 year prior to screening, or positive drug abuse screening test (including amphetamines (AMP), cocaine (COC), tetrahydrocannabinol (THC), morphine (MOP), benzodiazepines (BZO), and methamphetamines (MET), any one or more of which tested positive).
- Consumption of more than 14 units of alcohol per week within 6 months prior to screening (1 unit of alcohol equivalent to 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine), or consumption of alcohol-containing products within 48 hours before administration, or positive breath alcohol test before administration.
- Participation in other clinical trials of vaccines, medical devices, or other drugs within 12 months prior to screening
- Major surgery within 4 weeks prior to screening, or planned major surgery during the study.
- Participant with systolic blood pressure (SBP) < 90 mmHg or > 140 mmHg, or diastolic blood pressure (DBP) < 50 mmHg or > 90 mmHg after resting in a sitting position, or heart rate (HR) < 50 beats per minute (BPM) or > 100 bpm at rest in sitting position at the screening.
- Any other factors that may affect participation in this study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
A2Z Clinical Centro Avançado de Pesquisa Clínica LTDA
Valinhos, São Paulo, 13271-130
Paulo Fernandes, 19 3829-6160, paulo.fernandes@azdcro.com.br
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Bridging Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of Efsubaglutide Alfa in Healthy Adult Participants in Brazil
This is a Phase I, randomized, double-blind, placebo-controlled, single-dose study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011. Participants will be randomized to receive a single subcutaneous dose of YN-011 1 mg, YN-011 3 mg, or matching placebo. The study includes screening, approximately 2 days of study-site confinement from the day before dosing to 24 hours after dosing, and outpatient follow-up for 4 weeks. Assessments include safety monitoring, PK blood sampling, PD evaluations, and immunogenicity testing.
Read the detailed description
This is a Phase I, randomized, double-blind, placebo-controlled, single-dose, parallel-group study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011 following subcutaneous administration.
The study will be conducted at a single clinical study site in Brazil and will enroll approximately 48 healthy adult participants. Participants will be randomized into 2 dose cohorts, a 1 mg cohort and a 3 mg cohort. Within each cohort, participants will be randomized in a 5:1 ratio to receive a single subcutaneous dose of YN-011 or matching placebo. Overall, the study will include 3 treatment groups: YN-011 1 mg, YN-011 3 mg, and placebo. The placebo will be matched in appearance and administered using the same device format in order to maintain blinding.
The main objectives of the study are to assess the safety and tolerability of YN-011 after single-dose administration in healthy adult participants, to characterize its PK profile, to evaluate selected PD effects, and to assess immunogenicity. Safety evaluations will include adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and other appropriate clinical assessments. PK assessments will characterize the concentration-time profile of YN-011 after dosing. PD assessments will evaluate the biologic effects of YN-011 after administration. Immunogenicity assessments will evaluate whether participants develop an immune response to YN-011.
The study includes a screening period of up to 4 weeks, a study-site confinement period of approximately 2 days, and an outpatient follow-up period of 4 weeks, for a maximum total study duration of approximately 8 weeks per participant. Participants will be admitted to the clinical study site on the day before dosing and will undergo pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of YN-011 1 mg, YN-011 3 mg, or matching placebo in the abdomen using a prefilled auto-injector.
During the confinement period, participants will remain under close clinical observation and will receive a controlled diet with specified fasting and fluid intake restrictions around dosing. After completion of the post-dose confinement period, participants will be discharged from the clinical study site and will return for scheduled outpatient follow-up visits for PK blood sampling, safety monitoring, PD evaluations, and immunogenicity assessments.
The results of this study are expected to provide clinical information on the safety, PK, PD, and immunogenicity profile of single-dose YN-011 in healthy adult participants in Brazil.
- Conditions
- Diabete Type 2
- Being tested
- Efsubaglutide Alfa Injection, Placebo
- Keywords
- Efsubaglutide Alfa, Phase 1, Healthy Volunteers, Pharmacokinetics, Brazil, Bridging Study, GLP-1 Receptor Agonist
- 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.
Efsubaglutide Alfa InjectionDrug
Efsubaglutide alfa will be administered as a single subcutaneous injection at a dose of 1 mg or 3 mg on Day 1 in healthy adult participants. The study drug will be administered in the abdomen using a prefilled auto-injector.
PlaceboDrug
Matching placebo will be administered as a single subcutaneous injection on Day 1 in healthy adult participants. Placebo is identical in appearance and presentation to efsubaglutide alfa and will be administered in the abdomen using a matching prefilled auto-injector.
| Study group | Role | What they receive |
|---|---|---|
| YN-011 1mg | Experimental | Not described Receives: Drug: Efsubaglutide Alfa Injection |
| YN-011 3mg | Experimental | Not described Receives: Drug: Efsubaglutide Alfa Injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of YN-011
Measured: Predose through Day 29
Time to Maximum Observed Plasma Concentration (Tmax) of YN-011
Measured: Predose through Day 29
Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of YN-011
Measured: Predose through Day 29
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of YN-011
Measured: Predose through Day 29
Terminal Elimination Half-Life (t1/2) of YN-011
Measured: Predose through Day 29
Secondary outcomes (10)
Incidence and severity of adverse events
Incidence and severity of adverse events, including treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Measured: From informed consent through Day 29
Clinically significant changes in vital signs, clinical laboratory tests, and 12-lead electrocardiograms
Clinically significant changes in vital signs, clinical laboratory tests, including hematology, biochemistry, amylase, lipase, and urinalysis, and 12-lead electrocardiograms.
Measured: Baseline through Day 29
Change from baseline in fasting plasma glucose
Measured: Baseline through Day 29
Change From Baseline in Body Weight
Measured: Baseline through Day 29
Incidence of anti-drug antibodies and neutralizing antibodies
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs), if ADA positive.
Measured: Baseline through Day 29
Correlation Between AUC0-inf of YN-011 and Change From Baseline in Fasting Plasma Glucose at Day 29
Measured: Baseline and Day 29
Correlation between AUC0-inf of YN-011 and change from baseline in body weight at Day 29
Measured: Baseline and Day 29
Comparison of AUC0-inf of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants
Comparison of AUC0-inf of YN-011 between healthy adult Brazilian participants in this study and existing healthy-participant data from the Chinese Phase I clinical program.
Measured: Predose through Day 29
Comparison of AUC0-t of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants
Comparison of AUC0-t of YN-011 between healthy adult Brazilian participants in this study and existing healthy-participant data from the Chinese Phase I clinical program.
Measured: Predose through Day 29
Comparison of Cmax of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants
Comparison of Cmax of YN-011 between healthy adult Brazilian participants in this study and existing healthy-participant data from the Chinese Phase I clinical program.
Measured: Predose through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518121
- Sponsor's protocol ID
- YN011-I-102-BR
- Acronym
- BRIDGE-BR
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 8 Apr 2026
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Bridging Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of Efsubaglutide Alfa in Healthy Adult Participants in Brazil
- ClinicalTrials.gov ID
- NCT07518121
- Acronym / sponsor ID
- BRIDGE-BR / YN011-I-102-BR
- Conditions
- Diabete Type 2
- Keywords
- Efsubaglutide Alfa, Phase 1, Healthy Volunteers, Pharmacokinetics, Brazil, Bridging Study, GLP-1 Receptor Agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.University, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, randomized, double-blind, placebo-controlled, single-dose study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011. Participants will be randomized to receive a single subcutaneous dose of YN-011 1 mg, YN-011 3 mg, or matching placebo. The study includes screening, approximately 2 days of study-site confinement from the day before dosing to 24 hours after dosing, and outpatient follow-up for 4 weeks. Assessments include safety monitoring, PK blood sampling, PD evaluations, and immunogenicity testing.
Detailed description
This is a Phase I, randomized, double-blind, placebo-controlled, single-dose, parallel-group study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011 following subcutaneous administration.
The study will be conducted at a single clinical study site in Brazil and will enroll approximately 48 healthy adult participants. Participants will be randomized into 2 dose cohorts, a 1 mg cohort and a 3 mg cohort. Within each cohort, participants will be randomized in a 5:1 ratio to receive a single subcutaneous dose of YN-011 or matching placebo. Overall, the study will include 3 treatment groups: YN-011 1 mg, YN-011 3 mg, and placebo. The placebo will be matched in appearance and administered using the same device format in order to maintain blinding.
The main objectives of the study are to assess the safety and tolerability of YN-011 after single-dose administration in healthy adult participants, to characterize its PK profile, to evaluate selected PD effects, and to assess immunogenicity. Safety evaluations will include adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and other appropriate clinical assessments. PK assessments will characterize the concentration-time profile of YN-011 after dosing. PD assessments will evaluate the biologic effects of YN-011 after administration. Immunogenicity assessments will evaluate whether participants develop an immune response to YN-011.
The study includes a screening period of up to 4 weeks, a study-site confinement period of approximately 2 days, and an outpatient follow-up period of 4 weeks, for a maximum total study duration of approximately 8 weeks per participant. Participants will be admitted to the clinical study site on the day before dosing and will undergo pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of YN-011 1 mg, YN-011 3 mg, or matching placebo in the abdomen using a prefilled auto-injector.
During the confinement period, participants will remain under close clinical observation and will receive a controlled diet with specified fasting and fluid intake restrictions around dosing. After completion of the post-dose confinement period, participants will be discharged from the clinical study site and will return for scheduled outpatient follow-up visits for PK blood sampling, safety monitoring, PD evaluations, and immunogenicity assessments.
The results of this study are expected to provide clinical information on the safety, PK, PD, and immunogenicity profile of single-dose YN-011 in healthy adult participants in Brazil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YN-011 1mg | Experimental | Drug: Efsubaglutide Alfa Injection |
| YN-011 3mg | Experimental | Drug: Efsubaglutide Alfa Injection |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female adults, aged 18-45 years (both inclusive) at the time of signing the informed consent form (ICF).
- Body mass index (BMI) between 18-28 kg/m2 (both inclusive). Male participants must weigh no less than 50 kg, and female participants must weigh no less than 45 kg.
- Voluntary participation in this study, as documented by the written signature of two copies of the ICF.
- Negative serum pregnancy test for women of childbearing potential (WOCBP) during screening period. WOCBP and fertile male participants with WOCBP partners must use highly effective contraception methods without planning to become pregnant or to donate sperm or eggs throughout this study (from signing the ICF to at least 3 months after completion of this study).
- Be able to maintain good communication with the investigators and comply with all requirements of protocol to complete all trial procedures.
Key exclusion criteria (22 listed)
- Known or suspected allergy to the investigational medicinal product, its components or drugs of the same class, or a clinically significant drug allergy, or a history of atopic allergic disease.
- Previously or currently diagnosed diabetes mellitus (T1D or T2D) or prediabetes, according to the diagnostic criteria of the Brazilian Diabetes Society (SBD) guideline, defined by any of the following laboratory findings:
- History of clinically significant endocrine disorders that may affect glucose metabolism, body weight, or drug PK, including but not limited to Cushing's syndrome; acromegaly; pheochromocytoma; untreated or uncontrolled thyroid disorders (hyperthyroidism or hypothyroidism); polycystic ovary syndrome (PCOS) with metabolic abnormalities; adrenal insufficiency or other adrenal disorders; pituitary disorders affecting hormonal regulation.
- History of acute or chronic pancreatitis, symptomatic gallbladder disease (those who have recovered from cholecystectomy and have no sequelae after treatment are allowable to be enrolled), pancreatic injury or other high-risk factors that may lead to pancreatitis, or screening serum amylase or lipase >2X upper limit of normal (ULN).
- History of significant gastrointestinal (GI) disorders (e.g., gastroparesis, active ulcers within 6 months, or long-term use of medications that directly affect GI motility, or GI surgery within 6 months prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efsubaglutide Alfa InjectionEfsubaglutide alfa will be administered as a single subcutaneous injection at a dose of 1 mg or 3 mg on Day 1 in healthy adult participants. The study drug will be administered in the abdomen using a prefilled auto-injector. | Drug | YN-011 1mg, YN-011 3mg |
| PlaceboMatching placebo will be administered as a single subcutaneous injection on Day 1 in healthy adult participants. Placebo is identical in appearance and presentation to efsubaglutide alfa and will be administered in the abdomen using a matching prefilled auto-injector. | Drug | Placebo |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of YN-011
Time frame: Predose through Day 29
Time to Maximum Observed Plasma Concentration (Tmax) of YN-011
Time frame: Predose through Day 29
Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of YN-011
Time frame: Predose through Day 29
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of YN-011
Time frame: Predose through Day 29
Terminal Elimination Half-Life (t1/2) of YN-011
Time frame: Predose through Day 29
10 secondary outcomes
Incidence and severity of adverse events
Time frame: From informed consent through Day 29
Clinically significant changes in vital signs, clinical laboratory tests, and 12-lead electrocardiograms
Time frame: Baseline through Day 29
Change from baseline in fasting plasma glucose
Time frame: Baseline through Day 29
Change From Baseline in Body Weight
Time frame: Baseline through Day 29
Incidence of anti-drug antibodies and neutralizing antibodies
Time frame: Baseline through Day 29
Correlation Between AUC0-inf of YN-011 and Change From Baseline in Fasting Plasma Glucose at Day 29
Time frame: Baseline and Day 29
Correlation between AUC0-inf of YN-011 and change from baseline in body weight at Day 29
Time frame: Baseline and Day 29
Comparison of AUC0-inf of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants
Time frame: Predose through Day 29
Comparison of AUC0-t of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants
Time frame: Predose through Day 29
Comparison of Cmax of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants
Time frame: Predose through Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- 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.
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 Efsubaglutide Alfa Injection in people with Diabete Type 2, run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. at 1 site in Brazil.
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 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allen Guo (+86-13913843023, Yinghao.guo@innogenpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of YN-011 (time frame: Predose through Day 29). The study lists 5 primary outcomes in all. 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 8 Apr 2026.