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Effectiveness of Weight Loss Methods on Lifespan for Metabolic Syndrome
Plain-language guide to NCT06410352: phase 4 non-randomized trial of Semaglutide, 220 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06410352
- Phase
- phase 4
- Status
- recruiting participants
- Start
- 2024-03-01
- Completion (planned or actual)
- 2025-09-30
- Participants
- 220 (estimated)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Metabolic Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Semaglutide.
Treatment of T2D is complicated by arterial hypertension and obesity (metabolic syndrome - MS).
It had four arms (groups): one (active comparator), Surgical weight loss (active comparator), Very-low-calorie-restriction diet (experimental) and Ramadan fast's weight loss (experimental).
The 2nd group (n=50) receives surgical method (laparoscopic MGB). These patients pass through additional pre-operation examination (blood tests and electrocardiography, esophagogastroscopy, ultrasound, and other necessary standard methods).
The registry classes the interventions as behavioral, dietary supplement, drug and procedure.
More on the Plan
At the 1 st stage of the study will screen 71 adult patients for eligibility aged 35 to 65 years with T2D and hypertension for the RF.
T2D was treated with Metformin, Sulfonylurea, GLP-1 agonists (exenatide, liraglutide), Glitazones in different combinations; hypertension was treated with beta-blockers, calcium channel blockers, diuretics, SGLT-2 Inhibitors (empagliflozin, canagliflozin) in different combinations.
Outcome measures: Primary endpoints: weight loss, fasting blood glucose, blood insulin level, systolic/diastolic BP.
Secondary endpoints: blood lipids, heel bone mineral density (HBMD), and EF.
Who Took Part
220 planned participants were the target.
It was open to people of any sex aged from 35 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Written informed consent;. T2D≥3-year with glucose lowering therapy including insulin;. 35-55 years old;. BMI≥27 kg/m2 for both sex, for Asian ethnicity;. Ongoing treatment with antihypertensive treatment;.
The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: \<34 age \>56 years old;; gestation or lactation;; hereditary diseases;.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
The Semaglutide group and the comparison group ran side by side rather than switching.
Being open-label, the Semaglutide study did not mask who received what.
It started in 2024-03-01 with completion listed for 2025-09-30.
It ran at 1 site in Kazakhstan.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Weight (time frame: Baseline, 24 weeks). Body mass index (time frame: Baseline, 24 weeks). Fat mass (time frame: Baseline, 24 weeks).
It also tracked 4 secondary outcomes, for example Total cholesterol, HbA1c, Triglycerides and High-density lipoprotein.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Semaglutide in 220 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.