NCT07140081Not yet recruitingPhase 1
A Research Study to Evaluate BLX-0871 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 Isoform-specific AMPK Activator BLX-0871 in Healthy Adults With a Body Mass Index (BMI) of 20 - 35 kg/m2
Source: ClinicalTrials.gov · Last updated 24 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study will test an oral medicine called BLX-0871, which is being developed to improve metabolic health by activating AMP-activated protein kinase (AMPK), a key regulator of energy balance. The main goal is to see if BLX-0871 is safe and well tolerated when given to healthy adults. The study will also measure how the body processes BLX-0871, including how quickly it is absorbed, how long it stays in the blood, and how it is eliminated. Another objective is to see whether food affects the absorption of BLX-0871. It will also look at how the drug affects the body by looking at markers of AMPK activity.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- Sept 2025
- Primary completion date
- Apr 2026
- Lead sponsor
- Biolexis Therapeutics
- Diseases
- Obesity
- NCT number
- NCT07140081
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 76
- From Sept 2025 to the primary completion date, Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nucleus Network St Kilda Road Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.