A Research Study to Evaluate BLX-7006 in Healthy Adults

NCT07140055 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: BLX-7006-CLN-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test an oral medicine called BLX-7006, which acts like the hormone Glucagon-like Peptide-1 (GLP-1) to help control blood sugar and body weight. Current GLP-1 medicines are given by injection. This study will see if BLX-7006 is safe, how the body processes it, and whether food changes how it is absorbed. The main goal is to see if BLX-7006 is safe and well tolerated. Secondary objectives of the study will measure how BLX-7006 moves through the body after an oral dose, including how quickly it is absorbed, how long it stays in the blood, and how the body removes it. It will also look at how the drug affects the body by looking at markers of glucose metabolism.

Conditions

Normal Healthy Volunteer; Safety After Oral Intake

Keywords

Obesity; Type 2 Diabetes; Metabolic Disorders; Normal Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• Number of participants who experienced Adverse Events (AEs)

  The safety and tolerability of oral BLX-7006 administration will be evaluated based on the incidence of adverse effects in subjects, as assessed according to CTCAE v5.0. The number of participants who experience an AE will be reported.

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

• Number of participants who experienced Serious Adverse Events (SAEs)

  The safety and tolerability of oral BLX-7006 administration will be evaluated based on the incidence of SAE in subjects, as assessed according to CTCAE v5.0. The number of participants who experience a SAE will be reported.

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

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

  The safety and tolerability of oral BLX-7006 administration will be evaluated based on the incidence of TRAEs in subjects, as assessed according to CTCAE v5.0. The number of participants who experience a TRAE will be reported.

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

Secondary Outcomes (9)

• Assess maximum observed drug concentration (Cmax)

  Up to 14 days after last dose in each cohort

• Assess time to maximum concentration (Tmax)

  Up to 14 days after last dose in each cohort

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

  Up to 14 days after last dose in each cohort

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

  Up to 14 days after last dose in each cohort

• Assess half-life (t½) plasma concentration

  Up to 14 days after last dose in each cohort

Study Arms (2)

BLX-7006 Oral Dose

EXPERIMENTAL

Participants will receive oral BLX-7006 as a single dose (in Part 1 or 2) or once daily for 7 days (in Part 3).

Drug: BLX-7006

Placebo to match BLX-7006

PLACEBO COMPARATOR

Participants will receive an oral placebo that looks like BLX-7006 but does not contain active drug as a single dose (in Part 1 or 2) or once daily for 7 days (in Part 3).

Drug: Placebo

Interventions

BLX-7006 DRUG

BLX-7006 Single or Multiple doses administered orally as a tablet

BLX-7006 Oral Dose

Placebo DRUG

Participants will receive matching placebo of BLX-7006 for each of the oral cohorts.

Placebo to match BLX-7006

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biolexis Therapeutics: lead

Study Sites (1)

Nucleus Network Brisbane Clinic

Brisbane, Queensland, Australia

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Metabolic Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Central Study Contacts

Jeremiah James Bearss, MD, PhD

CONTACT

(385) 476-3080; jbearss@biolexistx.com

Matthew Anthony, BS, BS

CONTACT

(385) 476-3080; manthony@biolexistx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)