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Effect of Aqueous Extracts of Cissus Quadrangularis and Dichrostachys Glomerata on GLP-1 Concentration and DPP-4 Activity in Overweight and Obese Adults

Plain-language guide to NCT06827002: phase 1, phase 2 randomized trial of Semaglutide, 248 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06827002
Phase
phase 1, phase 2
Status
active, not recruiting
Start
2023-03-29
Completion (planned or actual)
2026-02-23
Participants
248 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Obesity and Overweight; Appetite Regulation
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Semaglutide.

Obesity is a global health crisis affecting over 2.3 billion individuals worldwide.

This prospective study aims to evaluate the comparative effects of standardised Cissus quadrangularis extract (CQE) and Dichrostachys glomerata extract (DGE) on obesity-related parameters, focusing on their impact on glucagon-like peptide-1 (GLP-1) levels and dipeptidyl peptidase-4 (DPP-4) enzyme activity in obese subjects.

Parameters such as GLP-1 levels, DPP-4 activity, food intake, satiety, body weight, blood lipids, fasting blood glucose, and visceral fat mass will be measured at baseline and various intervals.

It had four arms (groups): Placebo Group (placebo comparator), Dichrostachys glomerata Extract (DGE) Group (experimental), Cissus quadrangularia Extract (CQE) Group (experimental) and Semaglutide Group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Obesity is a health burden affecting over 2.3 billion people of all ages globally.

The development and progression of obesity involve a complex pathogenesis, and several drugs have been developed to target these pathways.

In recent years, dipeptidyl peptidase-4 (DPP-4) inhibitors or gliptins, such as sitagliptin, saxagliptin, and vildagliptin, have been considered as a viable obesity management option.

Gliptins inhibit DPP-4, an enzyme known to deactivate the GLP-1 hormone, contributing to the development and progression of obesity and other metabolic diseases.

Who Took Part

Enrollment: 248 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Healthy males and non-pregnant/non-lactating females. Participants aged 18 to 65 years old. Participants with BMI between 25 and 34 kg/m². Participants willing to comply with the study protocol.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: participants younger than 18 years or older than 65 years; participants not available for the study period; morbid obesity (bmi \> 34.9 kg/m²).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2023-03-29 with completion listed for 2026-02-23.

It ran at 1 site in Cameroon.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Effect of DGE and CQE on participants GLP-1 level (time frame: Baseline (Week 0), Week 4, Week 8, Week 12 and Week 16). Effect of DGE and CQE on participants DPP4 activity (time frame: Baseline (Week 0), Week 4, Week 8, Week 12 and Week 16).

It also tracked 6 secondary outcomes, for example Effect of DGE and CQE on participants' energy Intake, Effect of DGE and CQE on participants Fasting blood glucose, Effect of DGE and CQE on participants BMI, Effect of DGEand CQE on participants Body weight, Effect of DGE and CQE on participants Body Fat percentage and Effect of DGE and CQE on participants Lipid Profile.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Semaglutide in 248 people.

Its status is active not 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.