CompletedPhase 1

Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults

Lead sponsor

The Affiliated Hospital of Qingdao University

Asset

Beinaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

Primary endpoints

•Peak Plasma Concentration (Cmax)•AUC0-t•AUC0-∞

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05226000

Org study IDRH-RCT-IS-002

Timeline

Milestones

Study start2020-07-07actual

Primary completion2020-12-01actual

Study completion2021-05-20actual

Study first posted2022-02-07actual

Last update posted2022-02-07actual

Assets

Investigational agents

Beinaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female aged between 18 and 70 years old (including the critical value).

•BMI meets the following requirements (a or b):

1. BMI>28 kg/m2;

2. BMI>24 kg/m2 with at least one of the following symptoms:

Vigorous appetite, hunger before meals unbearable, each meal into more food. Combined with hyperglycemia, hypertension, dyslipidemia, fatty liver in one or several.

Combined with weight-bearing joint pain. Obesity causes dyspnea or obstructive sleep apnea syndrome.

•The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG.

•The subjects have no family planning within 3 months and could select contraceptive method.

•Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion criteria

•Patients with type 1 diabetes or type 2 diabetes with a clear diagnosis;

•Fasting intravenous blood glucose ≥7 mmol/L or 75g during screening. Oral glucose tolerance test (OGTT) two hours after glucose load;

•Fasting venous blood glucose <2.8 mmol/L at screening, and/or those with a history of hypoglycemia;

•Those who complained of a weight change of >5% within 3 months before screening;

•Have used weight loss drugs or hypoglycemic drugs that may affect body weight within 4 weeks before screening;

•Drugs used within 4 weeks before screening that may cause significant weight gain: including systemic glucocorticoid therapy (lasting more than 1 week); tricyclic antidepressants; antipsychotic or antidepressant drugs; may interfere with blood sugar regulation Functional medicine; all proprietary Chinese medicines and Chinese herbal medicines;

•Those who have a clear history of malignant tumors,

•People with Cushing's syndrome, hypothyroidism, polycystic ovary disease or other genetic endocrine diseases or medical history;

•Those who have a history of bariatric surgery;

•Have a history of multiple endocrine tumors or a family history; have a history of medullary thyroid carcinoma or other tumors, a family history;

•History of acute and chronic pancreatitis;

•Moderate to severe gastrointestinal diseases with additional gastrointestinal motility disorders or obstructive enteropathy;

•Have a clear history of mental illness

Endpoints (6)

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.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Peak Plasma Concentration (Cmax)

Time frame:80 days

Cmax

concentration, descriptive

Primary/protocol endpoint

Area under the plasma concentration versus time curve (AUC)0-t

Time frame:80 days

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Area under the plasma concentration versus time curve (AUC)0-∞

Time frame:80 days

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

elimination half-life time(T1/2)

Time frame:80 days

Half-life

descriptive

Primary/protocol endpoint

The total clearance(CL)

Time frame:80 days

descriptive

Secondary/protocol endpoint

Incidence of Treatment Adverse Events

Time frame:80 days

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.