Obeldesivir for RSV Infection

No longer recruiting at 121 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Gilead Sciences

Must not be taking: Antimicrobials, Antivirals, Monoclonal antibodies

Disqualifiers: Hospitalization, Influenza, SARS-CoV-2, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of obeldesivir for treating adults with RSV, a common respiratory virus. Researchers seek to discover if this new drug can accelerate recovery and reduce symptom duration. Participants will receive either the actual drug or a placebo (a look-alike with no active ingredients) for five days. Suitable candidates include adults who have recently tested positive for RSV and have conditions like moderate-to-severe COPD or asthma that has worsened in the past year. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received any direct-acting antiviral drug or monoclonal antibody against RSV within 28 days or 5 half-lives before joining the trial.

Is there any evidence suggesting that obeldesivir is likely to be safe for humans?

Research has shown that obeldesivir has been tested for safety and effectiveness against the respiratory syncytial virus (RSV). In a study with low-risk patients, obeldesivir was generally safe and well-tolerated. After five days, participants showed a noticeable reduction in the virus's genetic material compared to a placebo.

Although specific safety data for obeldesivir in humans is not yet available, similar antiviral drugs, like remdesivir, have caused some side effects. However, the absence of widespread negative reports suggests that obeldesivir might be well-tolerated. This trial is in the early stages of human testing, so while some evidence of safety exists, researchers are still gathering detailed information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Obeldesivir is unique because it introduces a novel approach to treating RSV infection. Unlike standard treatments that primarily focus on relieving symptoms, Obeldesivir targets the virus directly, potentially reducing the severity and duration of the illness. Researchers are excited because its direct antiviral action could lead to faster recovery times and offer a more effective option for combating RSV, which is particularly beneficial for vulnerable populations like infants and the elderly. This direct mechanism of action sets Obeldesivir apart from existing treatments, which generally don't address the virus itself.

What evidence suggests that obeldesivir might be an effective treatment for RSV?

Research has shown that obeldesivir (ODV) might shorten the duration of symptoms from respiratory syncytial virus (RSV) infections. Some studies found it effective against recent strains of similar viruses, such as the one causing COVID-19, suggesting potential efficacy for RSV as well. In this trial, participants will receive either obeldesivir or a placebo to determine if obeldesivir can help nonhospitalized adults with RSV recover more quickly. The treatment is easy to take, requiring only a few pills and not interfering with other medications. Overall, these early findings suggest that obeldesivir could be a promising treatment for RSV. ^{2 3 6 7 8}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

Adults over 60, or those with moderate/severe COPD, asthma, bronchiectasis, interstitial lung disease (like pulmonary fibrosis), pulmonary hypertension, or chronic heart disease can join. They must have confirmed RSV infection within the past 3 days and show new or worsening symptoms of at least moderate severity.

Inclusion Criteria

I am over 60 and have not received an RSV vaccine.

RSV infection confirmed ≤ 3 days before randomization

I have recently developed or worsened symptoms of an RSV infection.

Exclusion Criteria

Pregnant at screening

I have a history of cystic fibrosis.

I have been on dialysis or had moderate to severe kidney problems in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive obeldesivir or placebo for 5 days

1 week

Daily visits (in-person or virtual) for 5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Weekly visits (in-person or virtual)

Long-term follow-up

Participants are monitored for RSV-related outcomes and safety through Day 29

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Obeldesivir

Trial Overview The trial is testing Obeldesivir's effectiveness in reducing symptom duration for nonhospitalized adults with acute RSV. Participants will either receive Obeldesivir or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: Placebo comparator: Obeldesivir Placebo Experimental Treatment 1 Intervention

Participants will receive obeldesivir placebo for 5 days

Group II: Obeldesivir (ODV) Experimental Treatment 1 Intervention

Participants will receive obeldesivir for 5 days

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

A total of 25 anti-obesity medications were withdrawn between 1964 and 2009, primarily due to adverse reactions related to their effects on monoamine neurotransmitters, with 80% of withdrawals supported by case reports.

The most common reasons for withdrawal included psychiatric disturbances, cardiotoxicity, and drug dependence, raising concerns about the safety of using medications that target neurotransmitters for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

Presatovir (GS-5806) is a promising oral antiviral that effectively inhibits the fusion of respiratory syncytial virus (RSV) with host cells, showing favorable safety and pharmacokinetic profiles in two phase 1 studies involving healthy adults.

The studies demonstrated that presatovir can be administered once daily without regard to meals, and its exposure increases in a dose-proportional manner, supporting its potential for further clinical trials in treating RSV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 First-in-Human, Single- and Multiple-Ascending Dose, and Food Effect Studies to Assess the Safety, Tolerability, and Pharmacokinetics of Presatovir for the Treatment of Respiratory Syncytial Virus Infection. German, P., Xin, Y., Chien, JW., et al.[2021]

GS-5806 is a highly effective oral RSV fusion inhibitor, showing a mean EC50 of 0.43 nM against various RSV clinical isolates and demonstrating dose-dependent antiviral efficacy in a cotton rat model.

In healthy human volunteers infected with RSV, GS-5806 resulted in a significant 4.2 log10 reduction in peak viral load and decreased disease severity compared to placebo, indicating its potential as a treatment for RSV infections in both infants and adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovery of an oral respiratory syncytial virus (RSV) fusion inhibitor (GS-5806) and clinical proof of concept in a human RSV challenge study. Mackman, RL., Sangi, M., Sperandio, D., et al.[2021]

A total of 4941 adverse event (AE) reports were identified for antiobesity medicines in Europe from 2007 to 2014, with over 90% classified as serious, including 159 deaths, highlighting significant safety concerns associated with these medications.

The most commonly reported serious AEs were cardiac (19%) and psychiatric disorders (18%), particularly linked to orlistat and rimonabant, indicating a need for ongoing safety monitoring despite the withdrawal of some products from the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance. Aagaard, L., Hallgreen, CE., Hansen, EH.[2018]

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

In a Phase 4 trial involving 222 patients with obesity and type 2 diabetes, rimonabant (20 mg/day) combined with lifestyle counseling led to significant improvements in body weight, body mass index, and HDL cholesterol after one year, compared to placebo.

Despite these benefits, rimonabant was associated with a deterioration in quality of life and showed no significant improvement in overall cardiovascular risk factors, leading to its suspension from the market due to psychiatric side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimonabant improves obesity but not the overall cardiovascular risk and quality of life; results from CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE). Boesten, JE., Kaper, J., Stoffers, HE., et al.[2019]

In a review of 170 adverse drug reaction reports related to the antiobesity drug sibutramine, 34% indicated label-inconsistent use, highlighting potential safety risks associated with its prescription.

The analysis revealed that common violations included not adhering to the recommended starting dose and prescribing the drug to patients with a history of drug abuse, and a Dear Doctor Letter aimed at promoting proper use was found to be ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Label-inconsistent use of sibutramine in spontaneous adverse drug reaction reports in Germany. Seebeck, J., Wulf, F., Sachs, B.[2019]

Ginsenoside Rb1 effectively reduces food intake and body weight in high-fat diet-induced obese rats without causing toxicity, suggesting it could be a safe option for obesity treatment.

Rb1 not only lowers fasting blood glucose and improves glucose tolerance but also appears to have additional beneficial effects on glucose regulation beyond just weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiobesity and antihyperglycemic effects of ginsenoside Rb1 in rats. Xiong, Y., Shen, L., Liu, KJ., et al.[2021]

Rimonabant, at a dosage of 20 mg per day, resulted in a significant weight loss of 4.7 kg compared to placebo after one year, indicating its efficacy as an anti-obesity agent in a meta-analysis of four trials involving 4105 participants.

However, rimonabant was associated with a higher incidence of adverse psychiatric events, including depressive mood disorders and anxiety, leading to a recommendation for increased monitoring by physicians due to the potential severity of these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the weight-loss drug rimonabant: a meta-analysis of randomised trials. Christensen, R., Kristensen, PK., Bartels, EM., et al.[2022]

Qsymia™, a once-daily oral capsule combining phentermine and extended-release topiramate, has been approved in the US for treating obesity, leveraging phentermine's appetite-suppressing effects and topiramate's ability to increase feelings of fullness.

The formulation is also being explored for potential benefits in treating sleep apnea and type 2 diabetes, indicating its broader therapeutic applications beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phentermine and topiramate extended release (Qsymia™): first global approval. Cameron, F., Whiteside, G., McKeage, K.[2021]

In a study involving healthy adults infected with RSV, presatovir effectively reduced viral load and disease severity in a dose-dependent manner, demonstrating its potential as a treatment for RSV infections.

Although some RSV strains developed resistance to presatovir during treatment, this resistance did not significantly impact the overall clinical outcomes, suggesting that presatovir remains an effective option for managing RSV despite the emergence of resistant strains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Resistance Assessment Following Administration of Respiratory Syncytial Virus (RSV) Fusion Inhibitor Presatovir to Participants Experimentally Infected With RSV. Stray, K., Perron, M., Porter, DP., et al.[2021]

Losing just 5% of body weight can lead to significant health improvements, but many individuals struggle to maintain weight loss through diet and exercise alone, highlighting the need for additional treatment options.

As of 2012, two new medications, lorcaserin and phentermine/topiramate, have been approved for long-term obesity treatment, and bariatric surgery is recommended for patients with severe obesity (BMI ≥40 or ≥35 with comorbidities) as a more intensive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity consults--comprehensive obesity management in 2013: understanding the shifting paradigm. Kushner, RF., Apovian, CM., Fujioka, K.[2018]

Oral lorcaserin is effective for weight management in obese and overweight adults, showing significant weight loss compared to placebo in three large studies over 12 months, with many participants achieving a ≥5% or ≥10% reduction in body weight.

Lorcaserin is generally well tolerated, with low rates of serious side effects like valvulopathy, and those who maintained weight loss after 12 months continued to do so better than those who switched to placebo, indicating its potential for long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lorcaserin: a review of its use in chronic weight management. Hoy, SM.[2021]

In a Phase 2b trial involving 61 lung transplant recipients with RSV infection, the RSV fusion inhibitor presatovir did not significantly reduce nasal RSV load or improve respiratory symptoms compared to placebo.

Despite the lack of efficacy in reducing RSV levels or improving lung function, presatovir was generally well tolerated by patients, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of presatovir for respiratory syncytial virus after lung transplant. Gottlieb, J., Torres, F., Haddad, T., et al.[2023]

GS-5245, an oral prodrug targeting the RNA-dependent viral RNA polymerase, shows broad antiviral activity against multiple coronaviruses, including SARS-CoV-2 variants like BA.1, in vitro and in mouse models.

In combination with the protease inhibitor nirmatrelvir, GS-5245 demonstrated increased efficacy against SARS-CoV-2, suggesting it could be a valuable addition to treatment strategies for COVID-19, particularly for patients needing more effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the oral nucleoside prodrug GS-5245 (Obeldesivir) against SARS-CoV-2 and coronaviruses with pandemic potential. Martinez, DR., Moreira, FR., Zweigart, MR., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06585150

Study of Obeldesivir to Treat Nonhospitalized Adults With ... The primary objectives of this study are to evaluate the efficacy of ODV in reducing the duration of symptoms and to evaluate the safety and tolerability of ODV ...

2. gileadclinicaltrials.com gileadclinicaltrials.com/study?nctid=NCT06784973

Study of Obeldesivir to Treat Children With Respiratory ... The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) ...

3. stanfordhealthcare.org stanfordhealthcare.org/trials/s/NCT06585150.html

Study of Obeldesivir to Treat Nonhospitalized Adults With ... The primary objectives of this study are to evaluate the efficacy of ODV in reducing the duration of symptoms and to evaluate the safety and tolerability of ODV ...

4. trial.medpath.com trial.medpath.com/clinical-trial/e4ad04d19b8b1629/nct06585150-obeldesivir-rsv-infection-treatment

Study of Obeldesivir to Treat Nonhospitalized Adults With ... Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection ... Outcome data and publication updates.

5. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf406/8210547

Efficacy and Safety of Obeldesivir in High-Risk ... Obeldesivir has a low pill burden, no clinically meaningful DDIs, and activity against recent SARS-CoV-2 subvariants [16–19]. Here, results of a ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06585150

NCT06585150 | Study of Obeldesivir to Treat ... The primary objectives of this study are to evaluate the efficacy of ODV in reducing the duration of symptoms and to evaluate the safety and tolerability of ODV ...

7. withpower.com withpower.com/trial/obeldesivir-for-rsv-edccb

Obeldesivir for RSV · Info for Participants There is no specific safety data available for Obeldesivir, but similar antiviral drugs like remdesivir have been associated with adverse reactions. Remdesivir, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309925002385

Efficacy and safety of obeldesivir in low-risk, non ... Obeldesivir was generally safe and well tolerated, with greater reduction of SARS-CoV-2 viral RNA copy number versus placebo at day 5.