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

Completed · Phase 1 · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID: NCT07186946
Run by: Thryv Therapeutics, Inc.
People needed: 16
Starts: 2025-09-15
Expected to finish: 2025-10-20
Last updated by the study team: 2026-01-14

Who can join

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

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.
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.
Exclusion and Restriction Criteria
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.

Where it is running

Dr. Vince Clinical Research — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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