Phase 1, Open-Label, Randomized, Study of the Safety and Pharmacokinetics of HU6

Completed · Phase 1

Conditions studied: Overweight

In brief

This is a five-part study being conducted to evaluate the safety, tolerability and pharmacokinetics of the HU6 tablet and capsule formulations at steady state in the fed and fasted state for HU6 450 mg once daily (QD) dose (as single or multiple tablets) or HU6 300 mg twice daily (BID) (supplied as two 150 mg tablets) or HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD or HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD.

Key facts

Study ID

NCT07170189

Run by

Rivus Pharmaceuticals, Inc.

People needed

59

Starts

2025-10-13

Expected to finish

2025-12-04

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female between 18 and 55 years of age at time of signing the informed consent.
• Body mass index (BMI) ≥ 25 kg/m2 at Screening.
• Medically stable in the opinion of the investigator based on medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations. Note that Screening abnormalities or findings outside the normal ranges for any clinical assessments that are considered clinically significant by the Investigator (clinical laboratory tests, ECG, vital signs) may be repeated once at the discretion of the Investigator(s), and results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation.
• Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this clinical protocol.

You may not qualify if…

• Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease as determined by the investigator and if deemed necessary, in consultation with the medical monitor, which may impact safety.
• History of cancer (except for treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
• Any surgical or medical condition or history that, in the opinion of the investigator, and if deemed necessary, in consultation with the medical monitor, may potentially alter the absorption, metabolism, or excretion of IMP, such as, but not limited to, gastric bypass surgery or gallbladder removal surgery or significant small bowel resections.
• Contraindication to IMP or its excipients and/or history of anaphylactic reactions or clinically significant allergic reaction.

Where it is running

• Nucleus Network — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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