Clinical Trial to Lose Weight While Preserving or Increasing Muscle Mass

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Eli Lilly Collaborates with Anti-Aging Company BioAge for Clinical Trial to Lose Weight While Preserving or Increasing Muscle Mass

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Eli Lilly Collaborates with Anti-Aging Company BioAge for Clinical Trial to Lose Weight While Preserving or Increasing Muscle Mass

In June 2022, the FDA approved Novo Nordisk’s semaglutide (Semaglutide) as a weight loss medication, and it quickly gained global popularity, generating over $10 billion in sales that year.

Semaglutide is a peptide-based GLP-1 receptor agonist, and in previous clinical trials, it achieved a weight loss effect of up to 15% in obese patients (administered once a week at 2.4mg per dose over 68 weeks).

Eli Lilly’s GIP/GLP-1 receptor dual agonist, tirzepatide, has achieved the most substantial weight loss effect to date.

On October 15, 2023, Eli Lilly, in collaboration with several research institutions, including the University of Pennsylvania, published a study in the prestigious medical journal Nature Medicine.

The results of the Phase 3 clinical trial named SURMOUNT-3 revealed that after a 12-week intensive lifestyle intervention (including low-calorie diet, exercise, and frequent counseling), participants who were obese or overweight but did not have diabetes experienced an average weight loss of 26.6% (29.2 kilograms) over 72 weeks of tirzepatide treatment, for a total duration of 84 weeks. This data set a new record for the weight loss effect of tirzepatide when used continuously for 72 weeks.

On October 26, 2023, BioAge Labs announced their collaboration with Eli Lilly, with Eli Lilly’s support for a more health-focused weight loss clinical trial. The financial details of this collaboration have not been disclosed, but BioAge will retain exclusive rights to develop and commercialize all indications of Azelaprag globally. BioAge is set to combine their oral Apelin receptor agonist, Azelaprag (BGE-105), with Eli Lilly’s GIP/GLP-1 receptor dual agonist, tirzepatide, in a Phase 2 clinical trial. The trial is expected to officially commence in mid-2024 and will primarily target weight loss, with secondary objectives focused on potential benefits. Additionally, BioAge will collect aging-related biomarker information from participants.

Azelaprag is an agonist of the Apelin receptor, mimicking the activity of Apelin. Apelin is a “exercise factor” peptide released after physical activity. Apelin acts on skeletal muscle, the heart, and the central nervous system, regulating metabolism and promoting muscle regeneration. BioAge’s research indicates that overall Apelin levels tend to decrease gradually throughout a person’s life, and individuals with higher Apelin levels tend to have better physical function and longer lifespans.

In preclinical mouse models, BioAge combined Azelaprag with tirzepatide, resulting in better weight loss outcomes compared to using tirzepatide alone. BioAge suggests that the combination of Azelaprag and tirzepatide has benefits in energy metabolism, increased insulin sensitivity, and reduced fat mass.

In December 2022, BioAge released the results of a Phase 1b human clinical trial for Azelaprag, which showed that Azelaprag could prevent muscle atrophy in healthy elderly individuals aged 65 and older and maintain muscle protein synthesis.

Mainstream GLP-1-based drugs like semaglutide and tirzepatide have significant weight loss effects, but their core principle for weight loss is reducing the user’s appetite and calorie intake, which can lead to a loss of muscle mass.

In this collaboration, Eli Lilly will not only provide tirzepatide but also their clinical development team to support this new clinical research.

Dr. Kristen Fortney, CEO of BioAge, stated that this Phase 2 clinical trial aims to evaluate whether Azelaprag can significantly enhance the weight loss effects of gastrointestinal insulin-promoting (GLP-1, GIP) drugs.

This combination has the potential to improve the performance of both injectable and oral gastrointestinal insulin-promoting drugs. Azelaprag’s oral administration route makes it an exciting partner for the next generation of oral gastrointestinal insulin-promoting drugs currently in development.

Furthermore, Azelaprag has additional benefits that may contribute to promoting healthier weight loss.

Treating obesity may potentially prevent or delay various age-related diseases and significantly increase lifespans for a considerable portion of the population.

BioAge Labs is an anti-aging research company dedicated to developing therapeutic approaches for treating diseases and extending healthy lifespans by mapping the aging process in humans. The company has raised a total of $127 million in funding to date.

BioAge is currently pursuing three research areas for addressing metabolic and muscle aging, immune aging, and brain aging.

References:

• BioAge Labs
• Nature Medicine Article
• Business Wire Announcement

Eli Lilly Collaborates with Anti-Aging Company BioAge for Clinical Trial to Lose Weight While Preserving or Increasing Muscle Mass

(source:internet, reference only)

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