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

What this study is testing ClinicalTrials.gov NCT07195994 ↗

Description as written by the study sponsor.

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.

Treatments tested

• AMPK Charge+® Dietary supplement

  Participants will be instructed to consume 1 teaspoon (5 mL) on an empty stomach before breakfast and 1 teaspoon on an empty stomach in the afternoon and to hold the product in the mouth for approximately 30-90 seconds before swallowing starting on Day 1.

• AMPK Charge+® with semaglutide Dietary supplement

  Participants will be instructed to use the provided measuring tool to take 1 teaspoon (5 mL) on an empty stomach before breakfast and 1 teaspoon on an empty stomach in the afternoon and to hold the product in the mouth for approximately 30-90 seconds before swallowing starting on Day 1. Participants will be instructed to administer subcutaneous semaglutide once per week beginning with a dose of 0.25 mg for four weeks at which point participants will be instructed to increase the dose to 0.5 mg per week for the remainder of the study period.