OverweightPhase 1NCT07170189
Phase 1, Open-Label, Randomized, Study of the Safety and Pharmacokinetics of HU6
A Phase 1 study testing HU6 in people with Overweight, run by Rivus Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- HU6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to 4 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Five-Part Study to Assess the Pharmacokinetics and Safety of Tablet and Capsule Formulations of HU6 in Overweight Participants.
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.
Read the detailed description
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 450 mg once daily (QD) dose (as single or multiple tablets) or 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. Population pharmacokinetic (popPK) modeling indicated a potential difference in PK profile when multiple dose units are administered versus a single dose unit in tablet and capsule formulations.
- Conditions
- Overweight
- Being tested
- HU6
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HU6Drug
HU6 tablet or capsule
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Active Treatment HU6 450 mg tablet | Experimental | Drug: HU6 450 mg single tablet once daily (QD) Receives: Drug: HU6 |
| Experimental: Active Treatment HU6 150 mg x 3 tablets | Experimental | Drug: HU6 150 mg x 3 tablets QD Receives: Drug: HU6 |
| Experimental: Active Treatment HU6 (150 mg tablet × 2) BID | Experimental | Drug: HU6 300 mg dose (supplied as HU6 150 mg tablet × 2) BID (q12 hours) Receives: Drug: HU6 |
| Experimental: Active Treatment HU6 150 mg drug substance in a capsule × 3 (450 mg total) | Experimental | Drug: HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD Receives: Drug: HU6 |
| Experimental: Active Treatment HU6 150 mg granulated blend in a capsule × 3 (450 mg total) | Experimental | Drug: HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD Receives: Drug: HU6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
b. To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on the exposure parameter of maximum concentration (Cmax).
To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on exposure parameters of maximum concentration (Cmax), after multiple dose administration of the tablet and capsule formulations of HU6
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start13 Oct 2025
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rivus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170189
- Sponsor's protocol ID
- RIV-HU6-108
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Five-Part Study to Assess the Pharmacokinetics and Safety of Tablet and Capsule Formulations of HU6 in Overweight Participants.
- ClinicalTrials.gov ID
- NCT07170189
- Acronym / sponsor ID
- RIV-HU6-108
- Conditions
- Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Rivus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 450 mg once daily (QD) dose (as single or multiple tablets) or 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. Population pharmacokinetic (popPK) modeling indicated a potential difference in PK profile when multiple dose units are administered versus a single dose unit in tablet and capsule formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental: Active Treatment HU6 450 mg tablet | Experimental | Drug: HU6Drug: HU6 450 mg single tablet once daily (QD) |
| Experimental: Active Treatment HU6 150 mg x 3 tablets | Experimental | Drug: HU6Drug: HU6 150 mg x 3 tablets QD |
| Experimental: Active Treatment HU6 (150 mg tablet × 2) BID | Experimental | Drug: HU6Drug: HU6 300 mg dose (supplied as HU6 150 mg tablet × 2) BID (q12 hours) |
| Experimental: Active Treatment HU6 150 mg drug substance in a capsule × 3 (450 mg total) | Experimental | Drug: HU6Drug: HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD |
| Experimental: Active Treatment HU6 150 mg granulated blend in a capsule × 3 (450 mg total) | Experimental | Drug: HU6Drug: HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HU6HU6 tablet or capsule | Drug | Experimental: Active Treatment HU6 (150 mg tablet × 2) BID, Experimental: Active Treatment HU6 150 mg drug substance in a capsule × 3 (450 mg total), Experimental: Active Treatment HU6 150 mg granulated blend in a capsule × 3 (450 mg total), Experimental: Active Treatment HU6 150 mg x 3 tablets, Experimental: Active Treatment HU6 450 mg tablet |
Primary outcome
b. To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on the exposure parameter of maximum concentration (Cmax).
Time frame: 28 days
To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on exposure parameters of maximum concentration (Cmax), after multiple dose administration of the tablet and capsule formulations of HU6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HU6 in people with Overweight, run by Rivus Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
b. To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on the exposure parameter of maximum concentration (Cmax). (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.