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Semaglutide in Treatment of Obesity

Plain-language guide to NCT06604624: phase 3 randomized trial of Semaglutide, 462 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06604624
Phase
phase 3
Status
completed
Start
2024-09-20
Completion (planned or actual)
2025-08-27
Participants
462 (actual)
Design
randomized, single-blind, treatment
Conditions studied
Weight Management
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Semaglutide.

It had two arms (groups): HD1916 (experimental) and semaglutide (active comparator).

HD1916 will be administered via subcutaneous injection once a week in subjects with obesity.

Semaglutide will be administered via subcutaneous injection once a week in subjects with obesity.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 462 actual participants took part.

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: Age ≥18 years old (at the time of signing ICF), both male and female;. BMI≥28 kg/m\^2 during screening;. Voluntarily participate in the trial and sign the informed consent.

The full record lists 4 inclusion and 19 exclusion criteria; among the exclusions: received (including) drug therapy with glp-1 receptor agonists (single target, double target, or multiple target) within 90 days prior to screening;; past allergy or suspected allergy to glp-1 receptor agonists, or past allergy to investigational drug ingredients;; participated in any other trial and received at least one treatment in the 90 days prior to screening;.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Semaglutide was given.

Those kept unaware of assignments: participant.

It started in 2024-09-20 with completion listed for 2025-08-27.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Relative percentage change in body weight from baseline at 44 weeks of treatment (time frame: Baseline through Week44).

It also tracked 6 secondary outcomes, for example Changes in waist circumference from baseline at 44 weeks of treatment, Number of TEAE and SAE cases during the experiment, Changes in pulse from baseline at 44 weeks of treatment and Anti-drug antibodies, neutralizing antibodies (anti-drug antibody positive).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 462 people.

The trial is marked completed; 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.