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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
A Randomized, Single-blind, Controlled, Parallel 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
Lead sponsor
Assets
GLP-1 / incretin class catch-all / Semaglutide
Listed sites
1
Recruiting sites
1
Enrollment
90
estimated
Study population
Prediabetes / glucose intolerance, Type 2 diabetes
Key I/E criterion
•HbA1c 6-6.5%
Primary endpoints
•Fasting glucose, change•Change in fasting insulin between AMPK Charge+® and AMPK Charge+®•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Males \& females between 18 years of age or older
2. 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
Or,
Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
3. Individuals eligible for, but not currently taking, semaglutide therapy as per standard-of-care including adults with:
1. Prediabetes (HbA1c 6.0-6.5%) who are treatment naïve
2. Type 2 Diabetes (HbA1c 6.5-7.5%) who are treatment naïve and metformin is inappropriate due to contraindication or intolerance
4. Self-reported stable body weight defined as not having gained or lost more than 5 kg of body weight in the three months prior to baseline
5. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, sleep, use of nicotine, tobacco and cannabinoid products) as much as possible throughout the study
6. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
7. Provided voluntary, written, informed consent to participate in the study
Exclusion criteria
1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy, sensitivity, intolerance, or dietary restriction preventing use of study products
3. Personal or family history of MTC or in patients with MEN 2
4. Unstable metabolic disease or chronic diseases as assessed by the QI
5. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
6. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
7. Type I diabetes or diabetic ketoacidosis
8. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
9. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
10. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
11. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
12. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
13. Individuals with an autoimmune disease or are immune compromised
14. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
15. Self-reported confirmation of blood/bleeding disorders as assessed by the QI
16. Alcohol intake average of >2 standard drinks per day as assessed by the QI
17. Alcohol or drug abuse within the last 12 months
18. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the study products (See Section 7.3)
19. Clinically significant abnormal laboratory results at screening as assessed by the QI
20. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
21. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
22. Individuals who are unable to give informed consent
23. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Endpoints (25)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsThe difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in e. Body weight
Time frame:Day 0 to 84
Body weight, absolute change (kg)
change from baseline, improvement
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in e. Body weight
Time frame:Day 0 to 42
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
10 endpointsThe difference in change in fasting blood glucose between AMPK Charge+® and AMPK Charge+® with semaglutide
Time frame:Day 0 to 84
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
The difference in change in fasting insulin between AMPK Charge+® and AMPK Charge+® with semaglutide
Time frame:Day 0 to 84
change from baseline, improvement
The difference in change in hemoglobin A1c (HbA1c) between AMPK Charge+® and AMPK Charge+® with semaglutide
Time frame:Day 0 to 84
HbA1c, change
change from baseline, improvement
LOINC 4548-4
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting blood glucose
Time frame:Day 0 to 42
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in HbA1c
Time frame:Day 0 to 42
HbA1c, change
change from baseline, improvement
LOINC 4548-4
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in fasting insulin
Time frame:Day 0 to 42
change from baseline, improvement
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame:Day 0 to 42
HOMA-IR (insulin sensitivity)
change from baseline, improvement
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame:Day 0 to 84
HOMA-IR (insulin sensitivity)
change from baseline, improvement
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame:Day 0 to 84
HOMA-IR (insulin sensitivity)
change from baseline, improvement
The difference in change from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide in Postprandial glucose and insulin as assessed by an oral glucose tolerance test (OGTT)
Time frame:Day 0 to 84
Postprandial glucose
change from baseline, improvement
Cardiometabolic biomarkers
13 endpointsThe difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame:Day 0 to 42
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame:Day 0 to 42
LDL-C, change
change from baseline, improvement
LOINC 13457-7
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in High-Density Lipoprotein (HDL) cholesterol
Time frame:Day 0 to 84
HDL-C, change
change from baseline, improvement
LOINC 2085-9
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in , High-Density Lipoprotein (HDL) cholesterol
Time frame:Day 0 to 42
HDL-C, change
change from baseline, improvement
LOINC 2085-9
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Triglycerides (TG),
Time frame:Day 0 to 84
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Triglycerides (TG),
Time frame:Day 0 to 42
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in TC:HDL-C, TG:HDL-C, and LDL-C:HDL-C ratios
Time frame:Day 0 to 84
change from baseline, improvement
componentsTotal cholesterol, change, HDL-C, change, Triglycerides, change, LDL-C, change
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in TC:HDL-C, TG:HDL-C, and LDL-C:HDL-C ratios
Time frame:Day 0 to 42
change from baseline, improvement
componentsTotal cholesterol, change, HDL-C, change, Triglycerides, change, LDL-C, change
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Apolipoprotein B100 (ApoB100)
Time frame:Day 0 to 84
ApoB, change
change from baseline, improvement
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Inflammatory markers as assessed by C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)
Time frame:Day 0 to 84
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in Inflammatory markers as assessed by C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)
Time frame:Day 0 to 42
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in f. Framingham 10-year cardiovascular risk score (FCVRS)
Time frame:Day 0 to 84
change from baseline, improvement
The difference in change between AMPK Charge+® and AMPK Charge+® with semaglutide in f. Framingham 10-year cardiovascular risk score (FCVRS)
Time frame:Day 0 to 42
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.