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

NCT07186946 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: THRV-1268-0369
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. This study will also look at how the drug moves through the body, is absorbed, distributed, metabolized and eliminated.

Conditions

Heart Failure

Keywords

heart failure; obesity; cardiometabolic; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Evalute the safety and tolerability of a single oral dose

  -Occurance of treatment emergent adverse events

  7 days

Secondary Outcomes (5)

• Pharmacokinetic THRV-1268 Tmax

  From 0 to 24 hours

• Pharmacokinetic THRV-1268 t1/2

  From 0 to 24 hours

• Pharmacokinetic THRV-1268 Cmax

  From 0 to 24 hours

• Pharmacokinetic THRV-1268 AUC0-t

  From 0 to 24 hours

• Evaluate and compare the bioavailability

  From 0 to 24 hours

Study Arms (2)

Single Ascending Dose (SAD) THRV-1268 low dose (100mg)

EXPERIMENTAL

In Period 1 of cohort 1 will receive a single oral dose of THRV-1268 100mg

Drug: THRV-1268; Drug: Placebo

THRVY-1268 high dose (200mg)

EXPERIMENTAL

In cohort 2, will receive a single oral dose of THRV-1268 200mg

Drug: THRV-1268; Drug: Placebo

Interventions

THRV-1268 DRUG

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

Single Ascending Dose (SAD) THRV-1268 low dose (100mg); THRVY-1268 high dose (200mg)

Placebo DRUG

Placebo

Single Ascending Dose (SAD) THRV-1268 low dose (100mg); THRVY-1268 high dose (200mg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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).

Sponsors & Collaborators

• Thryv Therapeutics, Inc.: lead

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Heart Failure; Obesity; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In period 2 of cohort 1, relative bioavailability is unmasked
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: September 15, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (1)