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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuickSilver Scientific

About this trial

This is a randomized, single-blind, controlled, parallel clinical trial to examine the efficacy and safety of AMPK Charge+® with and without use of semaglutide on glycemic response in adults with prediabetes or Type 2 Diabetes. 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.

Eligibility criteria

Qualifiers

Males & females between 18 years of age or older

Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening

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)

Double-barrier method

Disqualifiers

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study

Allergy, sensitivity, intolerance, or dietary restriction preventing use of study products

Personal or family history of MTC or in patients with MEN 2

Unstable metabolic disease or chronic diseases as assessed by the QI

Trial design

Treatments tested in this trial

  • AMPK Charge+®
  • AMPK Charge+® with semaglutide

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

QuickSilver Scientific

Lead sponsor

KGK Science Inc.

Collaborator