Comparison of Body Weight Change Through Different Smeglutide Administration Methods

Fudan University

Status and phase: Not yet enrolling; Phase 4

Conditions: Weight Change, Body

Treatments: Drug: Semaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT05616052

2022-10-weight loss-SPHCC

Details and patient eligibility

About

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

Full description

Participants will be randomized into either group. One group will start from 0.25mg per week for four weeks, then increase to 0.5mg per week for four weeks, and 1mg per week maintenance dose for 8 weeks. The other group dosage regime depends on the tolerance of the semaglutide from participants. The dosage will stabilize on the dose how much participant could tolerate. At the end of 16 weeks treatment, comparison will be carried out on weight change before and after treatment and (1) Comparison of different administration methods (standards and titrations) on participant compliance, appetite and quality of life improvement; (2) Comparison of metabolism (waist hip circumference, body fat and body composition, blood pressure, blood lipid, blood glucose, insulin resistance) in different administration modes; (3) Comparison of adverse reactions of metabolic drugs in different administration modes.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

standard arm

Active Comparator group

Description:

standard arm will start from 0.25mg per week for four weeks, then increase to 0.5mg per week for four weeks, and 1mg per week maintenance dose for 8 weeks..

Treatment:

Drug: Semaglutide

titration arm

Active Comparator group

Description:

Titration arm dosage regime depends on the tolerance of the semaglutide from patients. The dosage will stabilize on the dose which patients could tolerate

Treatment:

Drug: Semaglutide