Nextida GC-B for Prediabetes

Overseen By Marc Moulin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rousselot BVBA

Must not be taking: Cannabinoids, Tobacco, Alcohol, others

Disqualifiers: Diabetes, Cancer, Autoimmune, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well Nextida GC-B, a new treatment, controls blood sugar levels in individuals with normal blood sugar or prediabetes. Participants will take either Nextida GC-B or a placebo (a harmless, inactive substance) before meals to assess its effect on post-meal blood sugar levels. Suitable candidates have maintained stable weight recently and have either normal blood sugar or prediabetes (where blood sugar levels are elevated but not yet classified as diabetes).

As an unphased trial, this study allows participants to contribute to early research that could provide new insights into managing blood sugar levels.

Will I have to stop taking my current medications?

The trial requires that you maintain your current medications as much as possible, but if you are taking any medications that might impact the study's safety or effectiveness, you may need to stop them. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that Nextida GC-B is likely to be safe for humans?

Research has shown that Nextida GC-B can help lower blood sugar levels by boosting a hormone called GLP-1, without raising insulin levels after meals. This could help people with prediabetes manage blood sugar spikes. Although specific safety details for humans aren't fully available, several trials have tested Nextida GC-B, suggesting it is likely safe. Studies in mice showed it helps control blood sugar without any reported side effects, which is reassuring. However, these findings are still under investigation, and ongoing trials will provide more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for prediabetes, which often involves lifestyle changes and medications like metformin, Nextida GC-B is a liquid shot taken before meals. This treatment is unique because it features a novel active ingredient designed to manage blood sugar levels more effectively. Researchers are excited about Nextida GC-B because it offers a convenient and potentially faster-acting alternative to traditional pills, with the potential for better adherence and improved outcomes in managing prediabetes.

What evidence suggests that Nextida GC-B might be an effective treatment for prediabetes?

Research has shown that Nextida GC-B, which participants in this trial may receive, might help manage blood sugar levels, crucial for individuals with prediabetes. Studies indicate that this treatment uses collagen peptides to increase the body's release of GLP-1, a hormone that helps control blood sugar after eating. One study found that these peptides reduced blood sugar spikes after meals by an average of 42% compared to a placebo.

Additionally, earlier research on mice demonstrated that a similar type of collagen improved the body's ability to handle sugar. These findings suggest that Nextida GC-B could effectively improve blood sugar control in humans, especially for those at risk of developing diabetes. ^{1 2 3 4 6}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

Adults aged 18+ with a BMI of 25-34.9, who have normal blood sugar levels or prediabetes (HbA1c ≤6.4%), can join this trial. They must be willing to maintain their current lifestyle and body weight, not be pregnant or planning pregnancy, and not have significant health issues like liver disease, cancer, immune conditions, recent major surgery or unstable hypertension.

Inclusion Criteria

I am willing to follow the study's requirements and attend all clinic visits.

Provided voluntary, written, informed consent to participate

BMI of 25 to 34.9 kg/m2

Exclusion Criteria

Excessive alcohol intake

I have difficult veins for drawing blood or giving IV treatments.

Clinically significant abnormal laboratory results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Nextida GC-B or placebo daily for 90 days to assess changes in glycemic control and other health markers

12 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nextida GC-B

Trial Overview The trial tests the effect of Nextida GC-B on blood sugar control in adults without diabetes but at risk for it. Participants will either receive Nextida GC-B or a placebo over 90 days to see how well it controls blood sugar after meals compared to before taking the drug.

How Is the Trial Designed?

Group I: Nextida GC-B Experimental Treatment 1 Intervention

This group receives one liquid shot of 5 g Nextida GC-B approximately 30 minutes before their two main meals (breakfast and lunch or breakfast and dinner) daily.

Group II: Placebo Placebo Group 1 Intervention

This group receives one liquid shot of placebo approximately 30 minutes before their two main meals (breakfast and lunch or breakfast and dinner) daily.

Who Is Running the Clinical Trial?

Rousselot BVBA

Lead Sponsor

Trials

8

Recruited

220+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07149064

Effect of Chronic Exposure to Nextida GC-B on Glycemic ... The goal of this clinical trial is to investigate the safety and efficacy of Nextida GC-B on glycemic control in adults with normoglycemia ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11606891/

A Specific Collagen Hydrolysate Improves Postprandial ... The data indicate that the specific collagen hydrolysate, H80, has significant GLP‐1‐mediated effects on oral glucose tolerance in lean and prediabetic mice.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07174323

Study Details | NCT07174323 | The Effects of Nextida-GC ... The main outcome of the study is the area under the curve of plasma glucose from 0 to 180 minutes. Official Title. The Effects of Nextida-GC and ...

4. nextida.rousselot.com nextida.rousselot.com/hubfs/HN/Brochures-WP/RLT-Nextida%20GC-Science_04-2025_V1.0_LR.pdf?hsLang=en

Targeting natural GLP-1 release with collagen peptides for ... Figure 8: A) Before the meal, 5- and 10 grams of Nextida GC supplementation triggered a small but significant insulin increase compared to ...

5. darlingii.com darlingii.com/rousselot/brands/nextida/nextida-gc

Nextida GC | Rousselot To target GLP-1, Rousselot developed specialty collagen peptides in Nextida GC. Supplementation reduced post-meal glucose spikes by 42% on average in a placebo ...

6. 8886786.fs1.hubspotusercontent-na1.net 8886786.fs1.hubspotusercontent-na1.net/hubfs/8886786/HN/RLT-Nextida%20GC-Science_09-2024_V1.0_LR.pdf

EXPLORE NEW FRONTIERS IN GLUCOSE CONTROL ... Figure 4: Oral supplementation of Nextida GC 45 min before an oral glucose load reduced the glucose spikes in lean, normoglycemic (A) and obese, ...