Safety Study of Oral BLX-7006 in Healthy Adults
Tests a new oral GLP-1 medicine for safety in healthy adults.
Plain-language title generated from the registry record
Registry title: A Research Study to Evaluate BLX-7006 in Healthy Adults
Key facts
- Where
- Brisbane, AustraliaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07140055, who can take part
Where in Australia
- Nucleus Network Brisbane ClinicBrisbane, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biolexis Therapeutics
- Trial code
- NCT07140055
- Record updated
- 24 August 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Prior gastrointestinal (GI) surgery affecting absorption (e.g., gastric bypass) or chronic GI disorders; 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); History of diabetes, clinically significant cardiovascular, hepatic, renal, gastrointestinal, psychiatric, or neurologic disease, or abnormal labs/Echocardiograms (ECG) deemed clinically relevant; 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; Any condition or history that may compromise safety, study conduct, or compliance, in the opinion of the Investigator.