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A Clinical Trial to Examine the Efficacy and Safety of an Investigational Product With and Without Use of Semaglutide on Glycemic Response in Adults With Prediabetes or Type 2 Diabetes

Plain-language guide to NCT07195994: not phased randomized trial of Semaglutide, 90 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07195994
Phase
not phased
Status
recruiting participants
Start
2026-02-05
Completion (planned or actual)
2026-09
Participants
90 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Prediabetes / Type 2 Diabetes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Semaglutide.

The main question it aims to answer is: What is the difference in change in fasting blood glucose and insulin, and hemoglobin A1c (HbA1c) from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide?

Participants will consume AMPK Charge+® with or without semaglutide injections and will be evaluated for glycemic response parameters.

It had two arms (groups): AMPK Charge+® (experimental) and AMPK Charge+® with semaglutide (active comparator).

AMPK Charge+® is a dietary supplement comprised of highly purified phospholipids, diindolylmethane, quercetin dihydrate, milk thistle seed extract, resveratrol, and berberine delivered using liposomal and nanoemulsion technology.

The registry classes the interventions as dietary supplement.

Who Took Part

Enrollment: 90 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: Males \& females between 18 years of age or older. Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System). Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s). Vasectomy of partner at least 6 months prior to screening. Abstinence and agrees to use contraception if becomes sexually active during this study.

The full record lists 15 inclusion and 23 exclusion criteria; among the exclusions: individuals who are pregnant, breast feeding, or planning to become pregnant during the study; personal or family history of mtc or in patients with men 2; unstable metabolic disease or chronic diseases as assessed by the qi.

How the Study Was Run

The set-up was randomized, parallel-group and single-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.

In this single-blind Semaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2026-02-05 with completion listed for 2026-09.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The difference in change in fasting blood glucose between AMPK Charge+® and AMPK Charge+® with semaglutide (time frame: Day 0 to 84). The difference in change in fasting insulin between AMPK Charge+® and AMPK Charge+® with semaglutide (time frame: Day 0 to 84). The difference in change in hemoglobin A1c (HbA1c) between AMPK Charge+® and AMPK Charge+® with semaglutide (time frame: Day 0 to 84).

It also tracked 22 secondary outcomes, for example The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting blood glucose, The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in HbA1c, The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting insulin, The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in High-Density Lipoprotein (HDL) cholesterol, The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in , High-Density Lipoprotein (HDL) cholesterol and The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Triglycerides (TG),.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 90 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.