BioAge Results for Phase 1b Clinical Trial on Anti Muscle-Aging Drug

This information came out in December, and was presented on at the Longevity Conference but I haven’t had time to cover it. Here are some details:

The results were discussed at the JP Morgan Biotech Conference a few weeks ago, as covered here: Video: Therapies to Target Muscle Aging (Wednesday, Jan. 11)

At the Longevity Summit Conference BioAge covered some of the muscle results of their BGE-105 Drug that looks as though it will preserve muscle strength during aging (or inactivity). Initially the drug will be targeted at muscle wasting that is common with bed-rest of elderly patients or patients in the ICU.

The broader market is, of course, for people who don’t want to lose muscle strength as they age (despite less activity).

Below are some of the slides that were presented at the Longevity Summit, and a the bottom of this page are details on the Phase 1b clinical trial results:

Full details on this new drug and the results from the Phase 1 B trial are below (from the press release):

BioAge Announces Positive Topline Results for BGE-105 in Phase 1b Clinical Trial Evaluating Muscle Atrophy in Older Volunteers at Bed Rest

Apelin agonist BGE-105 resulted in statistically significant improvement vs. placebo in muscle size, quality, and protein synthesis in volunteers ≥65 years old during 10 days of bed rest, with no serious adverse effects

Results support advancement to Phase 2 study of BGE-105 to prevent adverse muscle atrophy–related outcomes for older patients in the ICU

December 05, 2022

BioAge Labs, Inc. (“BioAge”), a clinical-stage biotechnology company developing therapeutics that target the molecular causes of aging to extend healthy human lifespan, today announced positive Phase 1b clinical data for BGE-105, a highly selective, potent, orally available small-molecule agonist of the apelin receptor APJ. BGE-105 treatment resulted in statistically significant prevention of muscle atrophy relative to placebo in healthy volunteers aged 65 or older after 10 days of strict bed rest.

Muscle atrophy—loss of muscle mass and strength—is a universal feature of human aging that increases the risk of multiple morbidities, shortens lifespan, and diminishes quality of life. Hospitalization and periods of forced inactivity greatly accelerate this loss in older people.

“The data from this Phase 1b study provide clinical validation of BioAge’s AI-driven discovery platform and demonstrate the power of our human-first approach to identify medically relevant drug targets,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “Our analysis of BioAge’s human aging cohorts revealed that the apelin pathway is a strong predictor of healthy longevity and muscle function, and now this has translated directly into our clinical finding that apelin pathway activation with BGE-105 improves muscle physiology in older adults. Today’s announcement is a milestone in BioAge’s mission to create a pipeline of drugs that treat disease and extend healthy lifespan by targeting the mechanisms of aging.”

BioAge’s analysis of proprietary human biobanks showed that apelin pathway activity, which declines with age, is positively associated with longevity, mobility, and cognitive function. Apelin, the natural ligand of APJ, is secreted by skeletal muscle in response to exercise and regulates multiple aspects of muscle metabolism, growth, and repair. BGE-105 binds APJ and activates apelin signaling. In April 2021, BioAge entered into an exclusive worldwide license agreement with Amgen, Inc. to develop and commercialize BGE-105 for all indications.

Study design and results

The double-blind, placebo-controlled trial evaluated the safety and pharmacodynamics of BGE-105. Twenty-one volunteers underwent 10 days of bed rest while receiving infusions of BGE-105 or placebo.

Volunteers on placebo (n=10) exhibited muscle atrophy, reflected by statistically significant reductions in thigh circumference and ultrasound measurement of vastus lateralis muscle dimensions (cross sectional area and thickness) and muscle quality (fatty degeneration).

Treatment with BGE-105 (n=11) significantly ameliorated muscle atrophy relative to placebo:

Muscle dimensions: Volunteers receiving BGE-105 showed a 100% improvement in thigh circumference (p < 0.001) relative to placebo-treated volunteers, and ultrasound measurements showed a 58% improvement in vastus lateralis cross-sectional area (p < 0.05) and a 73% improvement in vastus lateralis thickness (p < 0.01).

Muscle quality : Ultrasound echo density measurements revealed that the Goutallier grade, an index that quantifies fatty degeneration in muscle, worsened in 8 of 10 volunteers on placebo vs. only 1 of 11 volunteers receiving BGE-105 (p < 0.005).

Muscle protein synthesis : Proteomic analysis of muscle microbiopsy samples revealed that bed rest decreased production of muscle proteins, and this effect was significantly ameliorated by BGE-105 (p < 0.005). The higher rate of muscle protein synthesis in the drug vs. placebo group provides a potential mechanistic basis for BGE-105’s protective effect on muscle dimensions.

The drug was well tolerated in the study, consistent with prior phase 1 trials conducted by Amgen showing that oral or intravenous BGE-105 was safe and well-tolerated in 198 subjects.

“Older men and women lose substantial muscle mass during periods of immobilization and bed rest, often with devastating consequences,” said William Evans, PhD, Adjunct Professor at UC-Berkeley and Duke University. "Based on the promising data from this Phase 1b study, BGE-105 should be investigated for the treatment of a wide range of age-related syndromes driven by loss of muscle, including acute myopathies in hospitalized patients as well as chronic medical conditions that are common among millions of older people but lack effective therapies, representing an enormous unmet clinical need.”

Plans for advancement to Phase 2

BioAge plans to proceed with a Phase 2 trial of BGE-105 to prevent adverse outcomes in older patients under mechanical ventilation in the intensive care unit (ICU). The study will assess the ability of BGE-105 to prevent two conditions: ICU diaphragmatic atrophy and critical illness myopathy, a broad weakening of the muscles due to disuse under prolonged bed rest. These conditions, which affect millions of patients every year, are both associated with poor clinical outcomes and substantially increased mortality. No effective treatments are currently available, representing a high unmet medical need. The Phase 2 trial is anticipated to begin in 2023. The company will also continue to develop the drug for chronic conditions related to muscle aging.

Additional Reading:

BioAge Labs reports positive trial results for the treatment of muscle atrophy


Impressive on paper; it sounds like you need continuous BGE-105 to keep the muscle.
I am curious about what happened when the treatment group stopped receiving the medicine. Did they hold onto the muscle with activity? or did it start to atrophy pretty quickly?
The next study will be used in the ICU, where it could be a short-term intervention.


“Continuous use to get the benefits” is the basic pharma business model, so yes.

No details on how long the benefits continue but this initial indication is focused on stopping the huge amount of muscle loss that can happen very quickly during temporary ICU stay, or treatment that requires a few weeks bed rest. Longer term use results still tbd.


Correct, they{pharma business] wants the customer/patient coming back to purchase products for the rest of the person’s existence.

Reality is pharma business do not want any cure/one time treatment for any product they sell. Repeat con$umer is what they want.


Is it only me, or do those results seem too good to be true?


Does this mean no muscle loss for the treatment group versus some muscle loss for placebo? Or did the treatment group gain muscle over these 10 days?

I think that is just poorly worded. If you look up in the slides i think its a little clearer. I think what they are saying is that patients maintained 100% of their thigh circumference, ie. No physical shrinking of the thigh circumference.


Its basically the human equivalent to the mouse study mentioned in the slide before, you can see there was little to no atrophy in the immobilized mouse leg compared to the non-immobilized leg.

This all looks quite positive if we are interpreting it correctly but its still early, just a phase 1b trial. I look forward to the larger and more in depth phase 2/3 trials.

Not much info on the side effect profile… And a very short trial. Who knows if its something people can take for years…


It does seem like a really promising molecule, but as you said it’s still very early. I’d be curious to know what effect it would have on muscle with exercise. If it turned out to be safe, you could see people getting into shape for a few months and then just taking it to maintain their physiques. Beyond longevity the health and fitness aspect would be a huge market. But, I can’t imagine it would be free from side effects.


And did it do better than the already otc available, cheap and save HMB…

Yes, Exactly; that’s a very good point

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If a lab in India or China starts to crank up production of bgr-105 for sale as a research chemical, we might get thousands if test subjects in a few years. I am referring to bodybuilders and gym bros who are often taking research chemicals like LGE-4033. Of course the data from such unsupervised use is nearly worthless, but horrible side effects like liver toxicity or other surprise findings could be revealed. Between the gym bros, trans transitioners, and longevity biohackers, we have a lot of people trying to alter human physiology. There is much to be learned from all this self experimentation, but situation is so sloppy that a lot of wrong lessons may be learned first.


Yes, and not losing muscle seems a whole different kettle of fish than gaining muscle through exercise. We all seem to have a rough set point for musculature, and maybe this drug just makes it easy to maintain that, or maybe it makes it easier to exceed that set point…we just don’t know.

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I’ve been searching a big on Apelin to learn more. Here is one quote from the book “Defying Aging

“Another important myokine is called apelin. Of course, its levels decline with age but are boosted by exercise. Its effects read like a fountain of youth: stimulating production of new mitochondria, facilitating protein synthesis, and helping muscle stem cells to function.14
Our skeletal muscles suck up a large proportion of the sugar circulating in the blood. As we lose muscle, blood sugar levels can rise contributing to an age-related risk for type 2 diabetes. Conversely, exercise stabilizes blood sugar levels.1”

From the sounds of it, it will be competitive with drugs being developed that target Irisin: Irisin Ameliorates Age-associated Sarcopenia and Metabolic Dysfunction

Effect of endurance training on skeletal muscle myokine expression in obese men: identification of apelin as a novel myokine

Apelin_ijo.2013.158.pdf (1.2 MB)


I have a large amount of this product setting on my shelf. As with most butyrate products, they are quite nasty. I currently take potassium BHB because is highly hygroscopic and dissolves instantly in water and does not taste too bad. I take it like a shot of tequila with a water chaser.
The HYDROXYMETHYLBUTYRATE (HMB) is much nastier and doesn’t dissolve in water as well.
Does anyone have a favorite method of taking the nastier butyrate salts?

When I first read the study I thought they were saying there was a 100% gain in muscle, I.e. doubled in size.

A more in-depth discussion about BGR-105 for those who are interested:


Interesting stuff. But of course there have to be some negatives to apelin. It appears to be able to stimulate growth of tumors and even is said to be a marker for diagnosis of tumors.

It is suggested that apelin positively affects the treatment of non-cancerous diseases and may be considered as a therapeutic drug in many illnesses. However, in cancers, apelin appears as a tumour growth stimulator, and its suggested role is as a marker in the diagnosis of tumour cancers in tissues. In summary, apelin has certain therapeutic abilities and can be useful in the treatment of, e.g., insulin resistance, hypertension, etc., but it also can sometimes serve as a negative factor.

Full Paper (Open access)

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I see many research studies where drugs and supplements (e.g. NMN, etc.) seem to be helpful to our health when we are younger and disease free, but they seem to be helpful to the cancers (growth), and other disease conditions when people are older (if you have cancer, tumors, etc.).

I think this may be an argument for starting these drugs earlier in life (when the risk of you having undiagnosed cancer is lower). And it seems to suggest extra caution is in order if you are older and may have undiagnosed tumors and cancer.