Semaglutide's Weight Loss Effects in Obesity

NCT06825793 | Not Yet Recruiting

• 1 other identifier: 2025-Semaglutide-obesity
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a non-randomized, concurrent, parallel-controlled clinical trial. The objective of this trial is to determine the relationship between weight loss responsiveness to semaglutide in obese patients and their gut microbiota.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Body weight

  When measuring the subject's body weight, ensure shoes, hats, and heavy clothing or accessories are removed, and record the measurement to the nearest 0.1 kg.

  Weight changes will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatment

• Gut microbiota

  Using metagenomic sequencing to assess changes in the composition and abundance of gut microbiota between two groups of subjects. By analyzing the metagenomic data, we will identify specific microbial taxa and functional genes that show significant variation between the groups. This approach will provide insights into the microbial diversity, stability, and metabolic capabilities of the gut microbiome.

  Gut microtioba will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatment

Secondary Outcomes (3)

• Blood biochemical indicators

  Blood biochemical indicators will be measured at the following time points: before treatment, and at weeks 16 and 28 after treatment

• The blood concentration of semaglutide

  concentration of semaglutide will be measured at weeks 24 after treatment

• BMI

  BMI will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatment

Study Arms (2)

SLR group

SHAM COMPARATOR

Patients with a weight loss of less than 5% at the end of treatment are defined as semaglutide low responders (SLR).

Drug: Semaglutide Subcutaneous Injection

SHR group

ACTIVE COMPARATOR

Patients who experience a weight reduction of ≥15% at the treatment endpoint are defined as high responders to semaglutide (SHR).

Drug: Semaglutide Subcutaneous Injection

Interventions

Semaglutide Subcutaneous Injection DRUG

All subjects received subcutaneous injections of semaglutide over a 28-week treatment period, which included an initial 16-week dose-escalation phase. The escalation protocol began with a starting dose of 0.25 mg administered once weekly. Every 4 weeks, the dose was gradually increased in a stepwise manner to 0.5 mg, 1.0 mg, 1.7 mg, and finally 2.4 mg, each administered once weekly.

SHR group; SLR group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• BMI ≥ 30 kg/m²
• At least one self-reported unsuccessful attempt at lifestyle weight loss

You may not qualify if:

• Weight change (self-reported) \> 5% in the past 3 months prior to screening
• Use of any medication for obesity indication in the past 3 months prior to screening.
• Use of antidiabetic medications in the past 3 months, or HbA1c ≥ 6.5%, or a history of Type 1 or Type 2 diabetes.
• Use of immunosuppressants, corticosteroids, antidiarrheal drugs, antibiotics, probiotics, lipid-lowering medications, and/or other gastrointestinal motility drugs in the past 3 months prior to screening.
• A history of endocrine-related overweight or obesity diagnoses, such as Cushing's syndrome.
• Triglycerides ≥ 500 mg/dL (5.65 mmol/L) at screening.
• Known clinically significant gastric emptying abnormalities (e.g., severe diabetic gastroparesis or gastric outlet obstruction), gastrointestinal diseases, or surgical history.
• Thyroid dysfunction.
• History of mental illness.
• History or family history of multiple endocrine neoplasia or medullary thyroid cancer, or calcitonin ≥ 6 pg/mL.
• Abnormal liver function at screening, defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 3\*ULN.
• Abnormal kidney function at screening, defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.75m².
• History of cardiovascular disease.
• History of malignancy.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guang Wang

  Beijing Chao Yang Hospital

  STUDY CHAIR

Central Study Contacts

Jia Liu

CONTACT

010-85231710; liujia0116@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endocrinology

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 13, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-02