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Efficacy and Safety of Semaglutide for Weight Loss in Overweight or Obese Adults in Bangladesh With or Without Type 2 Diabetes Mellitus

Plain-language guide to NCT06616961: phase 3 interventional trial of Semaglutide, fat loss, obesity & body recomposition, 480 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06616961
Phase
phase 3
Status
not yet recruiting
Start
2024-11-01
Completion (planned or actual)
2025-02
Participants
480 (estimated)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Obesity; Type 2 Diabetes Mellitus (T2DM)
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Semaglutide for fat loss, obesity & body recomposition.

The main questions to answers are given below: Does semaglutide help participants lose weight after 26 weeks?

It had 1 arm (groups): Semaglutide (experimental).

The registry classes the interventions as drug.

More on the Plan

While surgical options are available for severe cases of obesity, they come with inherent risks and complications that necessitate ongoing follow-up care.

Among the medications approved for long-term use is semaglutide, a glucagon-like peptide-1 receptor agonist initially developed for the treatment of T2DM.

However, existing trials primarily include participants from Europe and North America.

Morphological differences exist between populations; for instance, central obesity is more prevalent among Caucasians, while subcutaneous fat accumulation is common in Asians.

Who Took Part

Enrollment: 480 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Common inclusion criteria for both diabetic and non-diabetic individuals. Informed consent will be obtained before any trial-related activities. Male or female, aged ≥ 18 years at the time of signing the informed consent form. Patients diagnosed with T2DM more than or equal to 180 days prior to the day of screening.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: treatment with any medication for the indication of obesity within the past 90 days before screening (eg. orlistat, liraglutide, naltrexone/bupropion, diethylpropion, phendimetrazine, and setmelanotide etc.); any previous obesity treatment with surgery or a weight loss device during lifetime; patient taking oral or injectable steroid for other indications.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Semaglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-11-01 with completion listed for 2025-02.

It ran at 1 site in Bangladesh.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Body Weight (kg) (time frame: 26 weeks).

It also tracked 11 secondary outcomes, for example BMI (kg/m²), Waist circumference (cm), HbA1C (%), FPG (mmol/l), Systolic blood pressure (mmHg) and Diastolic blood pressure (mmHg).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Semaglutide in 480 people with fat loss, obesity & body recomposition.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.

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.