ARGX-109 for Healthy Subjects

Overseen By Sabine Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: argenx

Disqualifiers: Medical, psychiatric conditions, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

32 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How is the drug ARGX-109 different from other treatments?

ARGX-109, which involves the use of L-arginine, is unique because it focuses on improving metabolic profiles by enhancing lean tissue deposition and reducing insulin resistance, which is not a common approach in many existing treatments. L-arginine is generally well-tolerated and has been shown to have beneficial effects on reducing white fat and improving health, making it a novel option for metabolic improvement. ^{1 2 3 4 5}

What is the purpose of this trial?

This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body. Each participant will remain in the study for approximately 20 weeks.

Eligibility Criteria

This trial is for healthy adults who want to help test the safety of a new medication called ARGX-109. Participants will be involved in the study for about 20 weeks.

Inclusion Criteria

My weight is between 50 and 100 kg and my BMI is between 18.5 and 30.

Exclusion Criteria

Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ARGX-109 or placebo to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ARGX-109

Trial Overview The trial is testing ARGX-109 against a placebo, which has no active drug. It's designed to see how safe ARGX-109 is and how it moves through and acts in the body over time.

Participant Groups

Group I: ARGX-109 Experimental Treatment 1 Intervention

Participants receiving the experimental drug

Group II: Placebo Placebo Group 1 Intervention

Participants receiving placebo

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University

Findings from Research

In a 13-week study with male and female Sprague-Dawley rats, L-arginine was found to have no significant toxicological or behavioral effects at dietary concentrations up to 5.0%, indicating it is safe for consumption at this level.

The study established a no-observed-adverse-effect level (NOAEL) for L-arginine at 5.0% (w/w), with only minor and physiologically insignificant changes in plasma glucose and red blood cell counts observed in some male rats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thirteen-week oral toxicity study of L-arginine in rats. Tsubuku, S., Hatayama, K., Mawatari, K., et al.[2013]

In a study involving 600 male Ross 308 broilers, dietary supplementation with crystalline arginine (Arg) at 100% of the recommended level significantly improved body weight gain, feed intake, and feed conversion ratio compared to lower levels (70% and 80%).

The research demonstrated that adequate Arg levels are crucial for enhancing bone mineral density and lean muscle mass in broilers, while lower Arg levels resulted in poorer growth and body composition outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

L-Arginine supplementation enhances growth performance, lean muscle, and bone density but not fat in broiler chickens. Castro, FLS., Su, S., Choi, H., et al.[2020]

Oral l-Arginine (Arg) supplementation, up to about 20 g per day, is generally safe and well-tolerated, even in vulnerable populations like pregnant women and preterm infants.

Recent studies indicate that Arg may improve metabolic profiles, particularly in individuals with obesity, insulin resistance, and diabetes, suggesting its potential as a beneficial nutriceutical for enhancing nutrient metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Arginine in Adults. McNeal, CJ., Meininger, CJ., Reddy, D., et al.[2023]

A clinical trial involving 101 overweight or obese adults showed that daily supplementation with 30 g of L-arginine (Arg) for 90 days is safe and well-tolerated, with no adverse events reported.

Supplementation with 30 g of Arg significantly reduced systolic blood pressure and serum glucose levels in women, and decreased free fatty acid concentrations in both men and women, indicating potential health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of dietary supplementation with arginine in adult humans. McNeal, CJ., Meininger, CJ., Wilborn, CD., et al.[2018]

Oral arginine (Arg) does not enhance growth hormone (GH) secretion at rest or during exercise in either young (average age 22) or older individuals (average age 68), based on a study involving 28 participants.

In fact, when Arg was taken during exercise, it appeared to blunt GH release in young individuals compared to exercise alone, suggesting that Arg may not be beneficial for stimulating GH secretion during physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral arginine does not stimulate basal or augment exercise-induced GH secretion in either young or old adults. Marcell, TJ., Taaffe, DR., Hawkins, SA., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Thirteen-week oral toxicity study of L-arginine in rats. [2013]

2. England pubmed.ncbi.nlm.nih.gov

L-Arginine supplementation enhances growth performance, lean muscle, and bone density but not fat in broiler chickens. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Arginine in Adults. [2023]

4. Austria pubmed.ncbi.nlm.nih.gov

Safety of dietary supplementation with arginine in adult humans. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Oral arginine does not stimulate basal or augment exercise-induced GH secretion in either young or old adults. [2019]