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RecruitingPhase NA

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

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, changeChange 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

NCT IDNCT07195994
Org study ID24QSCFA02

Timeline

Milestones

Study first posted2025-09-29actual
Study start2026-02-05actual
Last update posted2026-03-16actual
Primary completion2026-09estimated (month precision)
Study completion2026-09estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Prediabetes / glucose intoleranceType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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:

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
Intrauterine devices
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

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

Cardiometabolic biomarkers
13
Glycemic / diabetes
10
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

The 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

Secondary/protocol endpoint

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 endpoints
Primary/protocol endpoint

The 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

Primary/protocol endpoint

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

Primary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

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

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.