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BRIDGE-BR

Not yet recruitingPhase 1

A Bridging Study of Efsubaglutide Alfa in Healthy Adults in Brazil

A Randomized, Double-Blind, Placebo-Controlled Bridging Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of Efsubaglutide Alfa in Healthy Adult Participants in Brazil

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

48

estimated

Study population

Healthy volunteers

Key I/E criteria

BMI 18-28Healthy volunteers

Primary endpoints

Cmax of YN-011Cmax (Tmax) of YN-011AUC

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07518121
Org study IDYN011-I-102-BR

Timeline

Milestones

Study first posted2026-04-08actual
Last update posted2026-04-08actual
Study start2026-06-01estimated
Primary completion2026-08-01estimated
Study completion2026-10-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Healthy male or female adults, aged 18-45 years (both inclusive) at the time of signing the informed consent form (ICF).

2. 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.

3. Voluntary participation in this study, as documented by the written signature of two copies of the ICF.

4. 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).

5. Be able to maintain good communication with the investigators and comply with all requirements of protocol to complete all trial procedures.

Exclusion criteria

1. 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.

2. 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).

3. 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.

4. 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).

5. 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.

6. History or presence of hepatic, renal, cardiovascular, neurological, psychiatric, psychological or immunological disorders.

7. 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.

8. 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.

9. 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).

10. 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).

11. Pregnant or breastfeeding women.

12. Donation or loss of ≥400 mL of blood within 3 months prior to screening.

13. 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).

14. 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.

15. Participation in other clinical trials of vaccines, medical devices, or other drugs within 12 months prior to screening

16. Major surgery within 4 weeks prior to screening, or planned major surgery during the study.

17. 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.

18. Any other factors that may affect participation in this study at the discretion of the investigator.

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
13
Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline through Day 29

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change from baseline in fasting plasma glucose

Time frame:Baseline through Day 29

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

13 endpoints
Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of YN-011

Time frame:Predose through Day 29

Cmax

concentration, descriptive

Primary/protocol endpoint

Time to Maximum Observed Plasma Concentration (Tmax) of YN-011

Time frame:Predose through Day 29

Tmax

descriptive

Primary/protocol endpoint

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

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of YN-011

Time frame:Predose through Day 29

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Terminal Elimination Half-Life (t1/2) of YN-011

Time frame:Predose through Day 29

Half-life

descriptive

Secondary/protocol endpoint

Incidence and severity of adverse events

Time frame:From informed consent through Day 29

Treatment-emergent AEs (any)

descriptive, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Clinically significant changes in vital signs, clinical laboratory tests, and 12-lead electrocardiograms

Time frame:Baseline through Day 29

descriptive

Secondary/protocol endpoint

Incidence of anti-drug antibodies and neutralizing antibodies

Time frame:Baseline through Day 29

Immunogenicity (ADA)

threshold achievement, event

componentsImmunogenicity (ADA)

Secondary/protocol endpoint

Correlation Between AUC0-inf of YN-011 and Change From Baseline in Fasting Plasma Glucose at Day 29

Time frame:Baseline and Day 29

AUC₀–∞

descriptive

Secondary/protocol endpoint

Correlation between AUC0-inf of YN-011 and change from baseline in body weight at Day 29

Time frame:Baseline and Day 29

AUC₀–∞

descriptive

Secondary/protocol endpoint

Comparison of AUC0-inf of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants

Time frame:Predose through Day 29

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Comparison of AUC0-t of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants

Time frame:Predose through Day 29

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Comparison of Cmax of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants

Time frame:Predose through Day 29

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.