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UnknownPhase 4

The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.

A Randomized Controlled, Open-label, Multi-center Study With 16-week Beinaglutide or Dulaglutide Assessing Effects on Glucose Control and Weight Loss in Type 2 Diabetes With Overweight or Obesity.

Assets

Beinaglutide / Dulaglutide / GLP-1 / incretin class catch-all

Listed sites

4

Recruiting sites

4

Enrollment

120

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI 24-35HbA1c 7-10%

Primary endpoint

HbA1c, change

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 IDNCT05005741
Org study IDBENEFIT 1

Timeline

Milestones

Study start2021-05-01actual
Study first posted2021-08-13actual
Last update posted2023-03-17actual
Primary completion2023-12-31estimated
Study completion2023-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age between 18 to 70 years old from all sex;

2. Diagnosed with type 2 diabetes and HbA1c between 7% to 10%;

3. BMI from 24 to 35kg/m² or waistline longger than 90cm(male)/85cm(female);

4. Volunteer to participate in the study with informed consent;

Exclusion criteria

1. Type 1 diabetes or other specific types of diabetes;

2. Taking drugs of GLP-1 receptor agonist、TZDs and SGLT2 inhibitor within 3 months of screening;

3. Taking insulin or insulin analogues more than 7 days within 3 months of screening;

4. Pregnancy, breastfeeding or planned pregnancy;

5. History of acute or chronic pancreatitis;

6. Taking glucocorticoids(oral or intravenous) continuously more than 7 days within 6 months of screening;

7. Alanine aminotransferase or aspartate transaminase more than 3 times of the normal upper limit, total bilirubin more than 2 times of the normal upper limit;

8. renal impairment (estimated glomerular filtration rate<60mL/min per 1.73 m²);

9. History of gastrointestinal disease;

10. History of malignant tumor within 5 years of screening;

11. History of organ transplantation or AIDS;

12. History of glaucoma;

13. History of hyperthyroidism or hypothyroidism;

14. History of medullary thyroid carcinoma or multiple endocrine neoplasia II;

15. History of abnormal of Calcitonin or thyroid tumor;

16. History of alcohol abuse;

17. Recruited by other clinical trials within 3 months of screening;

18. Taking drugs of weight loss within 3 months of screening;

19. History of bariatric surgery;

20. History of mental disorders;

21. History of rheumatic diseases or autoimmune diseases;

22. Allergic to beinaglutide or dulaglutide;

23. Participants who estimated would not be suitable for the study by the investigators.

Endpoints (13)

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

Weight & body composition
4
Glycemic / diabetes
4
Cardiometabolic biomarkers
4
MASH / liver
1

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Weight loss

Time frame:From baseline to 16 week.

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Body Mass Index(BMI)

Time frame:From baseline to 16 week.

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waistline

Time frame:From baseline to 16 week.

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Hipline

Time frame:From baseline to 16 week.

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

haemoglobin A1c(HbA1c)

Time frame:From baseline to 16 week.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

GLucose

Time frame:From baseline to 16 week.

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Homeostasis model assessment for insulin resistance(HOMA-IR)

Time frame:From baseline to 16 week.

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Homeostasis model assessment for β cell(HOMA-β)

Time frame:From baseline to 16 week.

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint

Adipose tissue of liver

Time frame:From baseline to 16 week.

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Serum total cholesterol

Time frame:From baseline to 16 week.

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Serum triglycerides

Time frame:From baseline to 16 week.

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Serum Low Density Lipoprotein-Cholesterol(LDL-C)

Time frame:From baseline to 16 week.

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Serum High Density Lipoprotein-Cholesterol(HDL-C)

Time frame:From baseline to 16 week.

HDL-C, change

change from baseline, improvement

LOINC 2085-9

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.