AzTrials
AzTrials

Heart FailurePhase 1NCT07186946

Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, PK, PD, and Comparative Bioavailability of THRV-1268 in Obese Adult Participants

A Phase 1 study testing THRV-1268 in people with Heart Failure, run by Thryv Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A research study that involves the use of an investigational drug called THRV-1268. The main purpose is to measure the safety (whether it causes any side effects) and tolerability (if it does cause any side effects, how well your body is able to handle them) in healthy obese adults. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Heart Failure
What is being tested?
THRV-1268
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteUnited States
Study dates
15 Sep 2025to 20 Oct 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

  • Provision of signed and dated Informed Consent Document (ICD).
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Healthy adult male or female participants.
  • If female, meets one of the following criteria:
  • Women of childbearing potential (WOCBP) who agrees to use any of the acceptable contraceptive methods:
  • Abstinence from heterosexual intercourse from Screening through at least 30 days from last study dose.
Show all 20Show fewer
  • One of the following highly-effective contraception methods:
  • intrauterine device (with or without hormones) used from at least 28 days prior to Screening through to at least 30 days from last study dose
  • male partner vasectomized at least 6 months prior to Screening visit
  • Double-barrier contraception method (e.g., condom and spermicide) used from 28 days prior to Screening through at least 30 days from last study dose Or
  • Physiological postmenopausal status, defined as the absence of menses for at least 12 months following cessation of all exogenous hormonal treatments (without an alternative medical condition) at Screening and prior to the first study drug administration.
  • Or
  • Surgically sterile, defined as those who have had hysterectomy, bilateral oophorectomy and/or bilateral salpingectomy, or bilateral tubal ligation/occlusion.
  • Male volunteers agree to use a double-barrier method (e.g., condom and spermicide) or agree to remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for 90 days following the study dose. Men who are biologically capable of fathering children must also agree to refrain from sperm donation for the duration of the treatment period and for at least 90 days after the last study dose.
  • Aged at least 18 years but not older than 55 years (both years inclusive) at screening.
  • Body mass index (BMI) more than or equal to 30.0 kg/m2 and up to 40.0 kg/m2 (both inclusive).
  • Body weight ≥ 90.0 kg.
  • Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 90 days prior to the first study drug administration).
  • Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings in the physical examination (including vital signs), safety clinical laboratory tests, and/or ECG, as determined by an Investigator.
  • Ability to swallow whole tablets.

Who cannot join

  • Clinically significant cardiovascular, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, or psychiatric disease, or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
  • Female who is lactating.
  • Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration or planning to be pregnant.
  • Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system.
  • Male participants who are undergoing treatment or evaluation for infertility.
  • The average of 3 BP measurements performed after resting supine quietly for at least 5 min, and approximately 1 min between each measurement:
Show all 41Show fewer
  • Screening or baseline (Day -1, Period 1) :
  • systolic BP <100 mmHg or >145 mmHg;
  • diastolic BP <50 mmHg or >95; or
  • pulse rate ≤ 50 beats per minute (bpm) using a validated digital BP device.
  • These can be repeated in triplicate once after an additional quiet resting period.
  • Orthostatic BP performed after at least 5 mins in supine position and then after standing for at least 2 minutes but no more than 3 minutes with a reduction in systolic BP >20 mmHg, or a reduction in diastolic BP >10 mmHg, using a validated digital BP device.
  • History of significant hypersensitivity to THRV-1268, kinase inhibitors or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
  • Screening and check-in at Period 1: 12-lead ECG demonstrating at least one of the following:
  • Heart rate ≤50 bpm or >100 bpm.
  • PR interval >200 ms;
  • QRS duration >110 ms, or
  • QTcF ≥ 450 ms in males and 470 ms in females;
  • atrioventricular block; branch bundle block, significant ST T wave abnormalities or flat T waves that could interfere with QT analysis
  • History or evidence of any of the following: myocardial infarction; cardiac valvulopathy; cardiac surgery revascularization (coronary artery bypass grafting or percutaneous, transluminal coronary angioplasty); unstable angina; cerebrovascular accident, stroke, or transient ischemic attack; pacemaker; AF, flutter, or nonsustained or sustained ventricular tachycardia; orthostatic hypotension or orthostatic dizziness or lightheadedness, pulmonary arterial hypertension; sick sinus syndrome, second- or third-degree atrioventricular block; uncontrolled hypertension; congestive heart failure; personal or family history of sudden death or long QT syndrome; unexplained syncope or syncope within the last 3 years regardless of etiology.
  • Immunization with a Coronavirus Disease (COVID-19) vaccine in the 14 days prior to the first study drug administration.
  • Scheduled immunization with a COVID-19 vaccine during the study that, in the opinion of an Investigator, could potentially interfere with participant participation, participant safety, study results, or any other reason.
  • Use of immunosuppressant in the 28 days or 5 half-lives (whichever is longer) prior to the first study drug administration.
  • Major surgery with prolonged immobilization in the 28 days prior to the first study drug administration.
  • Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
  • Any clinically significant illness in the 28 days prior to the first study drug administration.
  • Use of any over-the-counter or nutritional supplements in the last 7 days prior to the first study drug administration and during the study, that in the opinion of an Investigator would put into question the status of the participant as healthy.
  • Use of any prescription drugs (including hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an Investigator would put into question the status of the participant as healthy.
  • Use of St. John's Wort in the 28 days prior to the first study drug administration.
  • Any history of tuberculosis.
  • Hemoglobin value below the lower limit of the reference laboratory at Screening, unless deemed non-significant by the Investigator.
  • Abnormal screening values in potassium, magnesium, alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase, alkaline phosphatase, total bilirubin, and direct bilirubin values, unless deemed non-significant by the Investigator
  • Positive test result for urine alcohol and/or drugs of abuse at Screening or prior to the first drug administration.
  • Current or history of alcohol or substance abuse, with the exception of being fully recovered with no use of alcohol or substances of abuse within the 12 months prior to Screening
  • Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus antibody tests.
  • Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the participant's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
  • History of prior administration of THRV-1268 or inclusion in a previous cohort for this clinical study.
  • Treatment with any investigational product within 30 days or five half-lives of the drug (whichever is longer) prior to Screening.
  • Unable or unwilling to adhere to the lifestyle and dietary requirements described in Section 5.5.
  • Special diet or substantial changes in eating habits 1 month prior to Screening.
  • Donation of 500 mL or more of blood (blood services, clinical studies, etc.) in the 56 days prior to Screening or donation of plasma within 7 days prior to Screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dr. Vince Clinical Research

    Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Comparative Bioavailability (Unblinded) of THRV-1268 in Health Obese Adult Participants

A research study that involves the use of an investigational drug called THRV-1268. The main purpose is to measure the safety (whether it causes any side effects) and tolerability (if it does cause any side effects, how well your body is able to handle them) in healthy obese adults. This study will also look at how the drug moves through the body, is absorbed, distributed, metabolized and eliminated.

Conditions
Heart Failure
Being tested
THRV-1268, Placebo
Keywords
heart failure, obesity, cardiometabolic, atrial fibrillation
Medical subject headings
Heart Failure, Obesity, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THRV-1268Drug

    THRV-1268 a serum glucocorticoid regulated kinase 1 (SGK-1) inhibitor

  • PlaceboDrug

    Placebo

Study groups in NCT07186946
Study groupRoleWhat they receive
Single Ascending Dose (SAD) THRV-1268 low dose (100mg)ExperimentalIn Period 1 of cohort 1 will receive a single oral dose of THRV-1268 100mg
Receives: Drug: THRV-1268; Drug: Placebo
THRVY-1268 high dose (200mg)ExperimentalIn cohort 2, will receive a single oral dose of THRV-1268 200mg
Receives: Drug: THRV-1268; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evalute the safety and tolerability of a single oral dose

    -Occurance of treatment emergent adverse events

    Measured: 7 days

Secondary outcomes (5)

  1. Pharmacokinetic THRV-1268 Tmax

    Time to maximum observed plasma drug concentration

    Measured: From 0 to 24 hours

  2. Pharmacokinetic THRV-1268 t1/2

    half-life

    Measured: From 0 to 24 hours

  3. Pharmacokinetic THRV-1268 Cmax

    Maximum observed plasma drug concentration

    Measured: From 0 to 24 hours

  4. Pharmacokinetic THRV-1268 AUC0-t

    Area under the concentration-time curve (AUC) from time 0 to the time of the last measurable concentration

    Measured: From 0 to 24 hours

  5. Evaluate and compare the bioavailability

    To evaluate the relative bioavailability (Area under the plasma concentration versus time curve (AUC)) of THRV-1268 tablet relative to THRV-1268 API powder for oral

    Measured: From 0 to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start15 Sep 2025
  3. Primary completion20 Oct 2025
  4. Study completion20 Oct 2025

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07186946
Sponsor's protocol ID
THRV-1268-0369
Status last verified
Jan 2026
First submitted
15 Sep 2025
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing THRV-1268 in people with Heart Failure, run by Thryv Therapeutics, 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 20 inclusion and 41 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 14 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?

Evalute the safety and tolerability of a single oral dose (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07186946.

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 14 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT07186946 | AzTrials