Overview

Comparison of Body Weight Change Through Different Smeglutide Administration Methods

Status:
Not yet recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
All

Summary

Investigators determined to detect the effect of smeglutide on body weight and metabolic indexes among overweight and obese participants through two different dosing programs.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Huashan Hospital

Criteria

Inclusion Criteria:

1. 18 ≤ age<75;

2. Overweight or obesity: meet either one of the following standards

1. Patients with BMI ≥ 24 kg/m2 and at least one obesity complication (hypertension,
hyperlipidemia, apnea syndrome, cardiovascular disease)

2. Simple obese patients with BMI ≥ 28kg/m2

3. Abdominal obesity, waist circumference ≥ 90 cm for males and ≥ 80 cm for females

Exclusion Criteria:

1. Have a personal or family history of medullary thyroid carcinoma (MTC) or have
multiple endocrine neoplasia type 2 (MEN-2) patients.

2. Patients with severe hypersensitivity to smeglutide or any other excipient component.

3. Diabetic patients (glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥ 7.0
mmol/L or blood glucose ≥ 11.1 mmol/L 2 hours after meal or random blood glucose ≥
11.1 mmol/L).

4. Triglyceride>5.6mmol/L;

5. Participants in other clinical drug trials in recent three months.

6. The range of weight change in recent 90 days is>5kg.

7. Cushing's syndrome and abnormal thyroid function.

8. Pregnant or breastfed women.

9. The study doctor judged that it was not suitable to participate in the test.