Clinical Research · Peptide Evidence Program

Evidence, measured in every transcript.

We follow what peptide and incretin therapies actually do inside the body — visit by visit — by pairing whole-blood mRNA monitoring with clinical biomarkers, wearables and how participants feel. Every record is de-identified and unlocked only by the participant’s own consent key.

Register interest View study pipeline Fertility & epigenetics reviews
Whole blood
Brightfield · renderIllustrative
48Transcripts in core panel
6Study arms across program
7Visits per participant
100%Data held by participant
01 · Why transcripts

The earliest signal is written in RNA.

When a therapy engages a pathway, cells change which genes they transcribe — often within days. Those messenger-RNA shifts can appear before downstream changes in proteins, metabolites or the clinical picture, giving a dynamic read-out of whether and how a biological programme is responding.

Weight, HbA1c or a six-minute walk take weeks to months to move, and they tell you little about mechanism. A longitudinal transcript panel, sampled on a fixed schedule and compared against each person’s own baseline, lets us ask sharper questions: Is an inflammatory programme quieting? Are mitochondrial-biogenesis genes switching on? Does that pattern precede — or fail to predict — the outcomes that matter?

A window, not a biopsy.

Whole blood mostly reflects circulating immune cells. It does not mirror muscle, liver or skin one-to-one, and many transcript changes have no proven clinical meaning yet. That is why every study pairs RNA with established clinical markers — and why we treat transcript findings as hypotheses to test, not conclusions.

Large cohort work has shown that the peripheral-blood transcriptome carries reproducible biological information — for example, roughly 1,500 genes whose expression tracks chronological age across nearly 15,000 people.13

How signals unfold over time Conceptual schematic — not data
Conceptual cascade of biological signals after a therapy starts Schematic with three curves. Transcript changes rise first and peak early; protein and metabolite changes rise later; clinical outcomes change slowest and last. No real data are shown. mRNA protein clinical Therapy start Time → Relative change
Transcripts (solid violet) are sampled at every visit; proteins and metabolites (blue) and clinical outcomes (terracotta) are measured on a slower schedule. The shapes are illustrative of the typical ordering only — real response kinetics differ by pathway, tissue and person.

From a drop of blood to a dashboard.

The same five-step pipeline runs at every visit, so each participant becomes their own longitudinal control.

  1. Step 01

    Collect

    Venous draw at clinic visits, or an at-home finger-stick for interim time-points.

    Whole blood · fasted AM · time-stamped

  2. Step 02

    Stabilize

    Blood goes straight into an RNA-stabilizing tube so transcript levels are “frozen” at the moment of collection.

    Study-code label only · no name

  3. Step 03

    Assay

    RNA is extracted, quality-checked and reverse-transcribed, then run on a 48-target RT-qPCR panel in replicate.

    RIN / purity QC · technical triplicates

  4. Step 04

    Normalize

    Each target is normalized to stable reference genes, then expressed as fold-change from that person’s own baseline.

    ΔΔCt · fold-change = 2−ΔΔCt

  5. Step 05

    Visualize

    Results land in the participant’s MyHelix wallet as longitudinal trend lines, alongside labs, wearables and symptom scores.

    Encrypted · participant-keyed

Substudy RNA-seq discovery arm. At baseline, week 12 and week 52, a consenting subset contributes an additional sample for whole-transcriptome sequencing — used to discover signatures the targeted panel misses and to decide what earns a place in future panel versions. V0 · V4 · V6
02 · The core panel

Forty-eight transcripts, seven pathways.

Targets were chosen for biological plausibility, detectability in whole blood and relevance to the mechanisms proposed for each therapy. Draft panel v0.9 — the final list is locked in each study protocol before first sample.

Inflammation & inflammasome

8 targets
  • TNF
  • IL1B
  • IL6
  • NLRP3
  • CXCL8
  • NFKBIA
  • PTGS2
  • IL10

Mitochondrial biogenesis & OXPHOS

8 targets
  • PPARGC1A
  • TFAM
  • NRF1
  • NDUFS1
  • COX5A
  • ATP5F1A
  • SIRT3
  • MFN2

Oxidative stress / NRF2

7 targets
  • NFE2L2
  • HMOX1
  • SOD2
  • NQO1
  • GPX1
  • TXNRD1
  • CAT

Tissue repair & angiogenesis

7 targets
  • VEGFA
  • TGFB1
  • EGR1
  • MMP9
  • TIMP1
  • HIF1A
  • KLF2

Metabolic & insulin signalling

6 targets
  • PPARG
  • SREBF1
  • INSR
  • IRS2
  • PDK4
  • CPT1A

Immune ageing & senescence

6 targets
  • CDKN1A
  • CDKN2A
  • FOXO3
  • LRRN3
  • CD248
  • NELL2

Reference genes for normalization

6 targets
  • ACTB
  • GAPDH
  • B2M
  • PPIB
  • HPRT1
  • TBP

Reference-gene stability is re-verified in each cohort; any gene that drifts with treatment is dropped from the normalization set.

MyHelix · Transcript trends Illustrative — not study data
Illustrative MyHelix fold-change dashboard (not study data) An invented example showing log2 fold-change from baseline across seven visits from baseline to week 52. The NFE2L2 line rises to about plus 0.9 by week 12 and plateaus; the TNF line falls to about minus 0.8 by week 12; the ACTB reference-gene line stays flat near zero. Values are fabricated for demonstration only and are not results from any Binary Helix study. +1.5+1.0+0.5 0−0.5−1.0−1.5 V0Wk 2Wk 4 Wk 8Wk 12Wk 26Wk 52 Visit log2 fold-change vs baseline NFE2L2 TNF ACTB

Your baseline is the control.

Participants see the same trend lines the study team sees — each transcript plotted as log2 fold-change against their own first visit, with reference genes shown for context and every point linked to the labs, wearable data and symptom scores collected that week.

The chart at left uses invented values purely to demonstrate the interface. Individual transcript results are research data: they are not diagnostic and should not be used to change treatment without a clinician.

Explore the MyHelix wallet
03 · Study pipeline

Five studies. Honest status.

Statuses below are the real stage of each protocol. We have no outcome data to report from any Binary Helix study yet — when we do, results will be posted here whether or not they are favourable.

BH-GLP Enrolling

GLP-1 Family Transcriptome Study

Does whole-blood gene expression shift in step with the metabolic and body-composition changes seen on incretin therapy — and can early transcript patterns help explain who preserves lean mass?

Design
Prospective, observational cohort; two arms
Arms
Semaglutide · Tirzepatide
Population
Adults already prescribed either medication by their own clinician; baseline taken before first dose where possible
Duration
52 weeks · 7 visits
Intervention
None assigned — the study does not prescribe or supply medication
  1. Concept
  2. Protocol
  3. Ethics review
  4. Enrolling
  5. Follow-up
  6. Read-out

Transcript endpoints

  • TNF
  • IL1B
  • NLRP3
  • PPARGC1A
  • NFKBIA
  • PDK4
  • SREBF1
  • + full 48-panel

Clinical endpoints

  • Body weight and DXA body composition, including lean-mass preservation
  • HbA1c, ApoB and hs-CRP
  • Resting heart rate, HRV, step count and sleep from wearables
  • Appetite, GI tolerability and quality-of-life questionnaires
Check eligibility
BH-MITO Protocol in IRB review

MOTS-c × SS-31 Mitochondrial Renewal

A mechanistic study asking whether two mitochondria-targeted peptides — one acting on metabolic signalling, one on the inner mitochondrial membrane — produce a measurable, coherent bioenergetic transcript signature in people.

Design
Interventional, randomized mechanistic protocol (draft)
Status
Under independent IRB review; enrollment will not open until IRB approval and any required regulatory determinations are complete
Protocol
HelixCare mitochondrial protocol
  1. Concept
  2. Protocol
  3. Ethics review
  4. Enrolling
  5. Follow-up
  6. Read-out

Primary transcript read-outs

  • NDUFS1
  • COX5A
  • PPARGC1A
  • NFE2L2
  • HMOX1
  • SOD2
  • TFAM

Exploratory transcripts

  • PCDH8
  • UNC13C
  • DAAM2
  • CTR9

Physiological & circulating markers

  • GDF-15 and FGF-21 (mitochondrial stress-responsive hormones)
  • Lactate / pyruvate ratio
  • VO2max by cardiopulmonary exercise test; HRV
BH-REPAIR Planned

BPC-157 / TB-500 Soft-Tissue Recovery Registry

Controlled human evidence for these peptides is scarce; most of what is known comes from animal models. Rather than assume benefit, a registry design lets us systematically document real-world use, recovery trajectories and adverse events — and generate hypotheses worthy of a proper randomized trial.

Design
Prospective observational registry with a standard-rehabilitation comparator group
Population
Adults with tendon, ligament or muscle injury under the care of a licensed clinician
Safety
Structured adverse-event capture at every visit
  1. Concept
  2. Protocol
  3. Ethics review
  4. Enrolling
  5. Follow-up
  6. Read-out

Candidate transcripts

  • VEGFA
  • EGR1
  • TGFB1
  • MMP9
  • TIMP1
  • IL6
  • KLF2

Clinical & functional endpoints

  • Validated pain and function scores; return-to-activity time
  • Ultrasound tissue imaging where clinically indicated
  • hs-CRP; safety labs (liver, kidney, blood count)
BH-SKIN Planned

GHK-Cu Dermal & Systemic Gene-Expression Study

GHK-Cu’s reputation rests largely on in vitro gene-expression analyses and small topical studies. This study would test whether those predicted expression changes are observable in human skin and blood.

Design
Planned vehicle-controlled topical arm plus an observational systemic arm
Sampling
Non-invasive skin tape-strip RNA; whole-blood panel
  1. Concept
  2. Protocol
  3. Ethics review
  4. Enrolling
  5. Follow-up
  6. Read-out

Candidate transcripts

  • COL1A1
  • COL3A1
  • ELN
  • MMP1
  • TIMP1
  • SOD2
  • NQO1

Clinical endpoints

  • Standardized skin imaging, elasticity and trans-epidermal water loss
  • Local tolerability; participant-rated skin quality
BH-RENEW Planned

Renepheresis™ Biological Age Study

Multi-omic “ageing clocks” are promising research tools but are not validated clinical endpoints. This study would measure how several independent clocks move — together or apart — across a course of Renepheresis™ sessions.

Design
Planned prospective study with pre-specified clock analyses
Programme
About Renepheresis™
  1. Concept
  2. Protocol
  3. Ethics review
  4. Enrolling
  5. Follow-up
  6. Read-out

Biological-age measures

  • DNA-methylation epigenetic clocks
  • Plasma proteomic age estimates
  • Whole-blood transcriptomic age signature13

Candidate transcripts

  • LRRN3
  • CD248
  • NELL2
  • CDKN2A
  • CDKN1A
  • FOXO3

Clinical & safety

  • Blood count, ferritin, albumin, immunoglobulins; functional fitness; PROs
Core schedule of assessments

Seven visits, one year.

Shown for BH-GLP. Other protocols adapt timing to their mechanism; exact windows are defined in each IRB-approved protocol.

BH-GLP schedule of assessments by visit. A check means the assessment is performed at that visit.
AssessmentV0
Base		V1
Wk 2		V2
Wk 4		V3
Wk 8		V4
Wk 12		V5
Wk 26		V6
Wk 52
RT-qPCR 48-panel YesYesYesYesYesYesYes
RNA-seq (substudy) Yes—No—No—NoYes—NoYes
HbA1c · ApoB · hs-CRP Yes—No—No—NoYesYesYes
DXA body composition Yes—No—No—NoYes—NoYes
Weight & vitals YesYesYesYesYesYesYes
Wearables (continuous) Continuous, participant-controlled sync throughout
Patient-reported outcomes YesYesYesYesYesYesYes
Future potential

On the horizon.

Hypotheses only. None of these has a protocol yet, and listing a compound here is not a claim that it works or is safe. Candidate read-outs are starting points for panel design.

ExploratoryAEDG

Epitalon

Synthetic tetrapeptide studied mostly in animal and cell models; hypothesis: influences telomere-maintenance and circadian gene programmes.

  • TERT
  • PER1
  • NR1D1
  • CDKN2A
ExploratoryTα1

Thymosin α-1

Immunomodulatory thymic peptide approved in some countries outside the US; hypothesis: shifts interferon and T-cell activation signatures.

  • IFNG
  • IL2RA
  • ISG15
  • MX1
ExploratoryLys-Pro-Val

KPV

Tripeptide fragment of α-MSH with preclinical anti-inflammatory data; hypothesis: dampens NF-κB–driven transcripts.

  • NFKBIA
  • TNF
  • IL1B
  • CXCL8
ExploratoryHeptapeptides

Selank / Semax

Neuroactive peptides used clinically in Russia with limited Western trial data; hypothesis: alter neurotrophic and stress-response signalling, read alongside HRV and sleep.

  • BDNF
  • NTRK2
  • FOS
  • FKBP5
ExploratoryGHRH + GHS

CJC-1295 / Ipamorelin

Growth-hormone secretagogue combination; hypothesis: GH/IGF-1 axis activation detectable via GH-responsive transcripts and serum IGF-1.

  • SOCS2
  • CISH
  • IGF1R
  • IGFBP3
ExploratoryKISS1R ligand

Kisspeptin

Hypothalamic regulator of the reproductive axis; hypothesis: hormone-panel-led study (LH, FSH, sex steroids) with exploratory blood transcripts.

  • KISS1R
  • AR
  • ESR1
  • FKBP5
04 · Evidence dossiers

What is known. What is not.

Each dossier summarizes the published record and grades its strength. An approved drug with large randomized trials and a peptide supported mainly by rodent studies should never be described in the same breath — so we don’t.

RCTHuman pilotAnimalIn vitroRegulatory
Incretin receptor agonists · BH-GLP

GLP-1 family: semaglutide & tirzepatide

Semaglutide is a long-acting GLP-1 receptor agonist; tirzepatide is a dual GIP and GLP-1 receptor agonist. Both are given as weekly injections and act on appetite regulation, gastric emptying and glucose-dependent insulin secretion.

Regulatory status: FDA-approved prescription medicines for type 2 diabetes and for chronic weight management in eligible adults. Available only with a prescription.

Mechanism

Receptor activation in the pancreas, gut and brain reduces appetite and food intake and improves glycaemic control. Anti-inflammatory and cardiovascular effects are under active study; how much is driven by weight loss versus direct receptor effects remains an open question — one that immune-cell transcript data may help inform.

Key published evidence

  • RCTSTEP 1 (semaglutide 2.4 mg): mean body-weight change of about −14.9% versus −2.4% with placebo at 68 weeks in adults with overweight or obesity without diabetes, alongside lifestyle intervention.1
  • RCTSURMOUNT-1 (tirzepatide): dose-dependent weight reduction at 72 weeks, up to a mean of about −20.9% at 15 mg versus roughly −3% with placebo.2
  • RCTSELECT (semaglutide): a 20% relative reduction in major adverse cardiovascular events in people with established cardiovascular disease and overweight or obesity, without diabetes.3
  • RCTBody composition: DXA sub-analyses show that total weight lost includes both fat and lean mass, which is why BH-GLP tracks lean-mass preservation explicitly.1

What we will measure

  • TNF
  • IL1B
  • NLRP3
  • PPARGC1A
  • NFKBIA
  • PDK4
  • SREBF1
  • CPT1A

Plus weight, DXA, HbA1c, ApoB, hs-CRP, wearables and GI-tolerability PROs.

Evidence grades are Binary Helix’s editorial summary of the cited literature, reviewed at each dossier update. They describe the strength of evidence for the compound in general, not suitability for any individual.

05 · Participate

Contribute evidence. Keep your data.

Registering interest does not enroll you in anything. A study coordinator will explain the full protocol, answer questions and walk you through informed consent before any sample is taken.

Eligibility at a glance

General overview only. Each study has its own full criteria, confirmed at screening.

Usually eligible

  • Adults aged 18 or over
  • Able to attend clinic visits or complete at-home collection
  • For BH-GLP: a current or new prescription for semaglutide or tirzepatide from your own clinician
  • Willing to use a MyHelix wallet

Usually not eligible

  • Pregnancy or breastfeeding
  • Active cancer treatment or immunosuppressive therapy
  • Blood transfusion in the past 3 months (alters blood RNA)
  • Participation in another interventional trial

How your data stays yours

  • Consent keys in your MyHelix wallet

    Your consent is issued as a cryptographic key you hold. Researchers can only access the data types and studies that key permits.

  • De-identified at source

    Samples and records carry a study code, never your name. The link between code and identity is held separately under strict access control.

  • Granular, revocable sharing

    Choose what to share — transcripts, labs, wearables, questionnaires — and change or revoke those permissions at any time, with a full access log.

  • Withdraw whenever you choose

    Leaving a study never affects your care. Withdrawal stops all future collection and use; data already included in completed, de-identified aggregate analyses cannot always be removed, and we will tell you exactly what that means before you consent.

Register interest

Hear when a study fits you.

We only ask for what we need to contact you. Nothing is sent from this prototype page.

Common questions

Will I receive my transcript results?
Yes — every result is delivered to your MyHelix wallet as it is processed. Because transcript panels are research measurements rather than validated diagnostic tests, they are presented with context and should not be used to change treatment without speaking to your clinician. Clinically significant findings from standard safety labs are handled according to each protocol.
Does joining BH-GLP mean I get semaglutide or tirzepatide?
No. BH-GLP is observational: it follows people whose own clinician has already decided to prescribe one of these medications. The study does not prescribe, supply or pay for medication.
Who reviews these studies?
Each protocol is reviewed by an independent Institutional Review Board before enrollment opens, and interventional protocols undergo any required regulatory review. Registry identifiers will be posted on this page as they are assigned.
What happens to my samples after the study?
Leftover samples are stored only if you separately opt in to biobanking, and only for the uses your consent key allows. You can ask for stored samples to be destroyed at any time.
06 · Publications & oversight

Open by default.

We commit to publishing protocols before read-out, analysis plans before unblinding, and results — positive, null or negative — in peer-reviewed or preprint form.

Publications pipeline

  • Peptide Evidence Program: rationale, design and statistical analysis plan

    Protocol paper covering BH-GLP and the shared transcript panel.

    In preparation

  • Analytical validation of a 48-target whole-blood RT-qPCR panel

    Reproducibility, reference-gene stability and finger-stick vs venous concordance.

    In preparation

  • BH-MITO protocol

    To be registered and published after IRB approval.

    Pending IRB

  • Study results

    No results yet. This space will list read-outs as each study completes.

    None to date

Scientific advisory board

Appointments are being finalized. Named members will be listed with their disclosures once confirmed.

Principal Investigator, Computational Genomics

Transcript panel design and longitudinal analysis.

Seat to be announced

Medical Monitor, Endocrinology & Metabolism

Participant safety and clinical endpoint oversight.

Seat to be announced

Advisor, Mitochondrial Medicine

BH-MITO mechanism and exercise physiology.

Seat to be announced

Lead Biostatistician

Pre-registered analysis plans and multiplicity control.

Seat to be announced

Bioethics & Data Governance

Consent-key architecture and participant rights.

Seat to be announced

Participant Advocate

Lived-experience voice on study design and communication.

Seat to be announced
References

Published literature cited

  1. Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384(11):989–1002.
  2. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205–216.
  3. Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023;389(24):2221–2232.
  4. Karaa A, Haas R, Goldstein A, et al. Randomized dose-escalation trial of elamipretide in adults with primary mitochondrial myopathy. Neurology. 2018;90(14):e1212–e1221.
  5. Thompson WR, Hornby B, Manuel R, et al. A phase 2/3 randomized clinical trial followed by an open-label extension to evaluate the effectiveness of elamipretide in Barth syndrome. Genet Med. 2021;23(3):471–478.
  6. Szeto HH. First-in-class cardiolipin-protective compound as a therapeutic agent to restore mitochondrial bioenergetics. Br J Pharmacol. 2014;171(8):2029–2050.
  7. Lee C, Zeng J, Drew BG, et al. The mitochondrial-derived peptide MOTS-c promotes metabolic homeostasis and reduces obesity and insulin resistance. Cell Metab. 2015;21(3):443–454.
  8. Kim KH, Son JM, Benayoun BA, Lee C. The mitochondrial-encoded peptide MOTS-c translocates to the nucleus to regulate nuclear gene expression in response to metabolic stress. Cell Metab. 2018;28(3):516–524.
  9. Reynolds JC, Lai RW, Woodhead JST, et al. MOTS-c is an exercise-induced mitochondrial-encoded regulator of age-dependent physical decline and muscle homeostasis. Nat Commun. 2021;12:470.
  10. Seiwerth S, Rucman R, Turkovic B, et al. BPC 157 and standard angiogenic growth factors. Gastrointestinal tract healing, lessons from tendon, ligament, muscle and bone healing. Curr Pharm Des. 2018;24(18):1972–1989.
  11. Goldstein AL, Hannappel E, Sosne G, Kleinman HK. Thymosin β4: a multi-functional regenerative peptide. Basic properties and clinical applications. Expert Opin Biol Ther. 2012;12(1):37–51.
  12. Pickart L, Margolina A. Regenerative and protective actions of the GHK-Cu peptide in the light of the new gene data. Int J Mol Sci. 2018;19(7):1987.
  13. Peters MJ, Joehanes R, Pilling LC, et al. The transcriptional landscape of age in human peripheral blood. Nat Commun. 2015;6:8570.
  14. Karaa A, Bertini E, Carelli V, et al. Efficacy and safety of elamipretide in individuals with primary mitochondrial myopathy: the MMPOWER-3 randomized clinical trial. Neurology. 2023;101(3):e238–e252.

Research disclaimer. This page describes planned, pending and enrolling research for informational purposes only. No Binary Helix study has reported outcome data; any chart labeled “Illustrative” uses invented values and is not study data. Transcript panels described here are research measurements, not diagnostic tests, and have not been cleared or approved by the FDA.

Except where explicitly stated (semaglutide and tirzepatide for their approved indications; elamipretide for Barth syndrome), the peptides discussed are not approved by the FDA for human use, and their safety and efficacy have not been established. Summaries of published studies do not imply that similar results will occur for any individual. Nothing on this page is medical advice or an offer of treatment; speak with a licensed clinician before starting, stopping or changing any therapy. Participation in any study requires informed consent under an IRB-approved protocol.

Last editorial review of evidence dossiers: September 2026.