A Research Study to Evaluate BLX-7006 in Healthy Adults
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiolexis Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BLX-7006
- Placebo
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov