THRV-1268 for Obesity

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Thryv Therapeutics, Inc.

Must not be taking: Immunosuppressants, St. John's Wort

Disqualifiers: Cardiovascular disease, Pregnancy, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, THRV-1268, to determine its safety and tolerability in healthy individuals with obesity. Researchers aim to understand how the body processes this drug, including its absorption and elimination. The study involves two groups: one receiving a low dose and the other a higher dose. Individuals with a BMI of 30 or higher and a weight of at least 90 kg might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires participants to stop using any prescription drugs, over-the-counter medications, or nutritional supplements 28 days before the study starts, unless the investigator decides they don't affect your health status. This means you may need to stop taking your current medications.

Is there any evidence suggesting that THRV-1268 is likely to be safe for humans?

Research shows that THRV-1268 is currently being tested for safety in humans. Specific information about side effects in people is not yet available. This study is in an early phase, providing limited details on how well people tolerate the drug. Researchers are primarily examining how the drug functions in the body, including its absorption and processing.

Earlier tests in labs or on animals indicated that THRV-1268 might prevent heart issues related to obesity. However, more research is necessary to confirm its safety in humans. As a phase 1 trial, this marks one of the first times the drug is tested in people, making the information gathered crucial for understanding its safety. Prospective participants should consider this when deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about THRV-1268 for obesity because it introduces a novel approach to managing weight. Unlike traditional treatments such as lifestyle modifications, medications like orlistat, or GLP-1 receptor agonists, THRV-1268 offers a new mechanism of action that might provide an alternative for those who haven't responded well to current options. This treatment's unique feature is its potential effectiveness at different doses, with both a high dose (200mg) and a low dose (100mg) being tested to optimize patient outcomes. By exploring these new dosing strategies, THRV-1268 could offer a more tailored and potentially more effective solution for managing obesity.

What evidence suggests that THRV-1268 might be an effective treatment for obesity?

Research has shown that THRV-1268 has promising results from early studies. It reduced heart failure and tissue thickening and scarring in initial experiments. Although limited data exists on its direct effect on obesity, it may aid weight management by influencing how the body converts food into energy. Early findings suggest that THRV-1268 may work well alone or with other treatments like empagliflozin, which helps control blood sugar. These encouraging early results have prompted further research into using THRV-1268 for obesity treatment. Participants in this trial will receive either a low dose (100mg) or a high dose (200mg) of THRV-1268 to further evaluate its potential for obesity treatment. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for obese adults who are generally healthy. It's designed to test the safety and tolerability of a new drug, THRV-1268. Participants must not have any serious health issues that could interfere with the study or pose additional risks.

Inclusion Criteria

Body mass index (BMI) more than or equal to 30.0 kg/m2 and up to 40.0 kg/m2

Non- or ex-smoker

Ability to swallow whole tablets

Exclusion Criteria

History of significant hypersensitivity to specific products

Abnormal ECG findings

Clinically significant illness prior to the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of THRV-1268 to evaluate safety, tolerability, and pharmacokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

What Are the Treatments Tested in This Trial?

Interventions

• THRV-1268

Trial Overview The study is testing THRV-1268, an investigational drug, against a placebo in obese adults. The focus is on how safe it is, how well participants can tolerate it, and its journey through the body including absorption and elimination.

How Is the Trial Designed?

Group I: THRVY-1268 high dose (200mg) Experimental Treatment 2 Interventions

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

Group II: Single Ascending Dose (SAD) THRV-1268 low dose (100mg) Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Thryv Therapeutics, Inc.

Lead Sponsor

Trials

3

Recruited

150+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07186946

NCT07186946 | Phase 1, Single Ascending Dose Study to ... Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, PK, PD, and Comparative Bioavailability of THRV-1268 in Obese Adult Participants.

2. thryvtrx.com thryvtrx.com/news/1268-ind-esc-2025-results

Thryv Therapeutics Receives FDA IND Clearance of THRV ... This in vivo study evaluated the effects of THRV-1268, both as a monotherapy and in combination with empagliflozin (Jardiance), an SGLT2 ...

3. thryvtrx.com thryvtrx.com/news/phase-1-dosing-thrv1268

Future Studies in Heart Failure and Atrial Fibrillation to ... In several preclinical models of heart failure, THRV-1268 mitigated the development of heart failure and fibrosis, and reduced heart failure ...

4. icer.org icer.org/wp-content/uploads/2025/10/ICER_Obesity_Evidence-Report_For-Publication_102925.pdf

Semaglutide and Tirzepatide for Obesity: Effectiveness and ... The findings contained within this report are current as of the date of publication. Readers should be aware that new evidence may emerge ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12385529/

A Short-Term Cost-Effectiveness Analysis of Tirzepatide ... Clinical efficacy was assessed by the proportion of patients achieving weight loss targets of ≥10%, ≥15%, ≥20%, ≥25%, and ≥30%, using data from ...

6. prnewswire.com prnewswire.com/news-releases/thryv-therapeutics-receives-fda-ind-clearance-of-thrv-1268-for-clinical-programs-in-heart-failure-and-atrial-fibrillation-and-presents-results-of-sgk1-inhibition-combined-with-jardiance-empagliflozin-an-sglt2-inhibitor-in-a-pr-302548339.html

Thryv Therapeutics Receives FDA IND Clearance of THRV ... Thryv announced that it has received a Study May Proceed letter from the FDA for its IND application to evaluate THRV-1268 in obese healthy ...

7. newswire.ca newswire.ca/news-releases/thryv-therapeutics-presents-benefits-of-therapeutic-sgk1-inhibition-with-thrv-1268-in-a-murine-model-of-atrial-fibrillation-at-american-heart-association-scientific-sessionshealth-855998940.html

Thryv Therapeutics Presents Benefits of ... These pre-clinical results demonstrate THRV-1268 effectively prevents the induction of obesity-related atrial fibrillation and atrial arrhythmia ...

8. mdpi.com mdpi.com/2673-4168/5/2/26

Efficacy and Safety of Tirzepatide for Weight Management ... Given the high prevalence of cardiovascular complications in obesity, this finding suggests that tirzepatide may offer long-term cardioprotective benefits.