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Not yet recruitingPhase 1

A Research Study to Evaluate BLX-7006 in Healthy Adults

A Phase 1 Randomized, Double-blind, Placebo-controlled Single-ascending Dose and Multiple-ascending Dose (SAD and MAD) Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Novel Glucagon-like Peptide-1 Receptor Agonist (GLP-1RA) BLX-7006 in Healthy Adults With a Body Mass Index (BMI) of 20 - 35 kg/m2

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

76

estimated

Study population

Healthy volunteers

Key I/E criteria

BMI 20-35HbA1c 4-7.8%Healthy volunteers

Primary endpoints

Treatment-emergent AEs (any)Serious AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07140055
Org study IDBLX-7006-CLN-001

Timeline

Milestones

Study first posted2025-08-24actual
Last update posted2025-08-24actual
Study start2025-09estimated (month precision)
Primary completion2026-04estimated (month precision)
Study completion2026-05estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Healthy males or females, 18-65 years, BMI 20-35 kilograms/meter² (kg/m²), weight ≥50 kilograms (kg).
Normal or clinically acceptable labs, vital signs
HbA1c <6.5%, non-fasting glucose 4.0-7.8 milimol/Liter (mmol/L)
Willing to follow contraception requirements, avoid alcohol, nicotine, and blood donation per protocol, and comply with all study visits and procedures.

Exclusion criteria

History of diabetes, clinically significant cardiovascular, hepatic, renal, gastrointestinal, psychiatric, or neurologic disease, or abnormal labs/Echocardiograms (ECG) deemed clinically relevant.
Prior gastrointestinal (GI) surgery affecting absorption (e.g., gastric bypass) or chronic GI disorders.
History or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2); malignancy within 5 years (except treated basal cell or in situ cervical cancer).
History of severe allergic reactions, seizures, or psychiatric hospitalization; positive drug, alcohol, or cotinine test.
Use of prescription drugs, Over the counter (OTC) /herbal supplements
Participation in another clinical trial or blood donation within 30 days (or 5 half-lives of prior drug).
Any condition or history that may compromise safety, study conduct, or compliance, in the opinion of the Investigator.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
8
Glycemic / diabetes
3
Other (unclassified)
1

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Serum fructosamine levels

Time frame:Up to 14 days after last dose in each cohort

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Insulin levels

Time frame:Up to 14 days after last dose in each cohort

change from baseline, improvement

Secondary/protocol endpoint

C-peptide levels

Time frame:Up to 14 days after last dose in each cohort

change from baseline, improvement

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

Number of participants who experienced Adverse Events (AEs)

Time frame:From first dose through End of Study (up to ~28 days per participant)

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of participants who experienced Serious Adverse Events (SAEs)

Time frame:From first dose through End of Study (up to ~28 days per participant)

Serious AEs (any)

event count, event

Primary/protocol endpoint

Number of participants who experienced Treatment-Related Adverse Avents (TRAEs)

Time frame:From first dose through End of Study (up to ~28 days per participant)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Assess maximum observed drug concentration (Cmax)

Time frame:Up to 14 days after last dose in each cohort

Cmax

concentration, descriptive

Secondary/protocol endpoint

Assess time to maximum concentration (Tmax)

Time frame:Up to 14 days after last dose in each cohort

Tmax

descriptive

Secondary/protocol endpoint

Assess the area under the concentration-time curve from time 0 to infinity (AUCinf)

Time frame:Up to 14 days after last dose in each cohort

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Assess the area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)

Time frame:Up to 14 days after last dose in each cohort

concentration, descriptive

Secondary/protocol endpoint

Assess half-life (t½) plasma concentration

Time frame:Up to 14 days after last dose in each cohort

Half-life

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Glucagon levels

Time frame:Up to 14 days after last dose in each cohort]

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.