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Clinical Trial

VV116 Pharmacokinetics & Safety in Mild/Moderate Hepatic Impairment – COVID-19 Study

by Dr. Michael Lee – Health Editor February 25, 2026

written by Dr. Michael Lee – Health Editor

A Phase 1 clinical trial has demonstrated that VV116, an oral antiviral medication for COVID-19, does not require dose adjustments for patients with mild or moderate hepatic impairment. The study, involving adults with varying degrees of liver function, found that overall exposure to the drug remained comparable to that of healthy individuals.

Researchers assessed the pharmacokinetics and safety of a single 0.3-gram oral dose of VV116 in participants with mild and moderate hepatic impairment, as defined by the Child-Pugh method, comparing them to a control group of healthy adults. Analysis of plasma samples collected over 72 hours revealed that the area under the curve (AUC) – a measure of overall drug exposure – was similar across all groups, with geometric mean ratios of 94.10% (90% confidence interval 71.59%-123.68%) for mild impairment and 97.72% (74.34%-128.44%) for moderate impairment, relative to the control group.

While maximum drug concentration (Cmax) was lower in both impairment cohorts, median time to maximum concentration (Tmax) and half-life (t1/2) remained consistent across all groups. Treatment-emergent adverse events were reported in 12.5% of the mild impairment group, 37.5% of the moderate impairment group, and 12.5% of the control group. These events were generally mild or moderate in severity, transient, and resolved without intervention. The increased incidence in the moderate impairment group was not deemed clinically significant, as the events were isolated and not linked to VV116 exposure levels.

No serious adverse events, deaths, or study discontinuations were recorded during the trial. VV116 is a deuterated remdesivir hydrobromide, and has received accelerated approval in China for the treatment of adult patients with mild-to-moderate COVID-19, according to reports from January 2023. The drug functions as a viral RNA-dependent RNA polymerase inhibitor, demonstrating broad activity against human coronaviruses, and has shown synergistic potential when combined with the 3CLpro inhibitor nirmatrelvir, as indicated in research published in September 2023.

A separate clinical trial is currently evaluating COVID-19 rebound rates following a five-day course of VV116 compared to nirmatrelvir-ritonavir. Remdesivir derivative VV116 has been reported to have promising antiviral effects against SARS-CoV-2 and positive therapeutic outcomes in clinical trials.

February 25, 2026 0 comments

Health

DMT Shows Rapid Antidepressant Effects in Phase IIa Trial

by Dr. Michael Lee – Health Editor February 18, 2026

written by Dr. Michael Lee – Health Editor

A single dose of dimethyltryptamine (DMT), a psychedelic compound, produced a significant reduction in depressive symptoms in adults with major depressive disorder (MDD), according to a phase IIa clinical trial published Wednesday in Nature Medicine.

The study, a randomized, placebo-controlled trial, involved 34 participants with moderate-to-severe MDD who had previously not responded adequately to conventional treatments. Researchers found that those receiving DMT, administered intravenously alongside psychotherapeutic support, experienced a greater reduction in depression scores compared to those receiving a placebo.

MDD affects millions globally and is a leading cause of disability, yet many patients do not achieve full remission with existing therapies like selective serotonin reuptake inhibitors (SSRIs), which can also carry unwanted side effects. The findings suggest a potential new avenue for treatment, though researchers caution that further investigation is needed.

Participants in the trial received either 21.5 mg of DMT fumarate or a placebo, infused over 10 minutes. The primary measure of effectiveness was the change in Montgomery–Åsberg Depression Rating Scale (MADRS) scores at two weeks post-treatment. The DMT group showed a mean reduction in MADRS scores that was significantly greater than the placebo group (mean difference = −7.35; 95% CI = −13.62 to −1.08; P = 0.023).

Improvements were observed as early as one week after the DMT infusion. Even as an open-label phase of the trial offered all participants a second DMT dose, researchers noted that the most substantial clinical improvements occurred within two weeks of the initial dose, and there was no significant difference in outcomes between those receiving one versus two doses. This suggests the rapid onset of effect may be a key characteristic of DMT as a potential antidepressant.

The trial also assessed response rates – defined as a 50% or greater reduction in MADRS scores – and remission rates – defined as a MADRS score of 10 or less. At two weeks, 35% of participants in the DMT group achieved a response, compared to 12% in the placebo group. Remission rates were 29% in the DMT group and 12% in the placebo group. Researchers emphasized these estimates should be interpreted cautiously due to the small sample size.

The treatment was generally well-tolerated, with most adverse events being mild to moderate. Common side effects included injection site pain, anxiety, insomnia, headache, and restlessness. No serious adverse events or deaths were reported. Transient increases in heart rate and blood pressure were observed immediately following the DMT infusion, but clinical evaluations revealed no significant abnormalities.

DMT differs from other psychedelic therapies, such as those utilizing psilocybin – a compound found in magic mushrooms – in its shorter duration of effect. Psilocybin’s effects typically last for several hours, requiring extended therapeutic sessions. DMT, in contrast, produces a brief period of subjective psychedelic effects lasting around 30 minutes when administered intravenously, potentially making it more practical for clinical implementation, according to researchers.

The study’s authors acknowledge limitations, including the small sample size and the predominantly White participant population, which may limit the generalizability of the findings. They also noted the possibility of functional unblinding due to the pronounced subjective effects of DMT. Further research, including larger, longer-term studies comparing DMT to existing treatments, is needed to confirm these findings and evaluate the long-term safety and efficacy of DMT for MDD.

ClinicalTrials.gov registration: NCT04673383.

February 18, 2026 0 comments

Health

Big Breakfast Composition Impacts Weight Loss, Appetite & Gut Health: Study

by Dr. Michael Lee – Health Editor February 16, 2026

written by Dr. Michael Lee – Health Editor

What you eat for breakfast, not just how much, can significantly impact appetite control, weight loss, and the composition of gut microbiota, according to a new study published February 11, 2026, in the British Journal of Nutrition.

Researchers at the University of Aberdeen conducted a randomized, crossover trial involving 19 overweight or obese adults, finding distinct effects from high-fiber and high-protein breakfasts within a calorie-restricted diet. The study investigated the impact of different macronutrient compositions on appetite, energy balance, and gut health markers.

The trial involved participants following a maintenance diet, followed by either a high-fiber weight loss (HFWL) diet or a high-protein weight loss (HPWL) diet, with a washout period between each phase. Both weight loss diets were designed around a “big breakfast” concept, with 45% of daily calories consumed in the morning. The HFWL diet emphasized sources like lentils, fava beans, buckwheat, and wheat bran, while the HPWL diet included fish, poultry, eggs, red meat, and dairy.

Participants on the HFWL diet experienced an average weight loss of 4.87 kg, compared to 3.87 kg on the HPWL diet. Both diets led to reductions in fat mass and fat-free mass, but the reduction in fat-free mass was more pronounced after the HFWL diet. Interestingly, the HPWL diet was found to promote greater feelings of fullness, or satiety, while the HFWL diet had a more positive impact on gut microbiota composition.

Analysis of fecal samples revealed significant differences in gut microbiota between the two diets. The HFWL diet was associated with increased levels of butyrate-producing bacteria, including Anaerostipes hadrus, Roseburia faecis, and Faecalibacterium prausnitzii. The HPWL diet, conversely, showed an association with the genus Streptococcus. Levels of Bifidobacterium, Faecalibacterium, and Roseburia were all higher with the HFWL diet.

Further analysis showed that total short-chain fatty acids (SCFAs), including acetate, butyrate, and propionate, were significantly lower in participants following the HPWL diet compared to those on the HFWL diet. SCFAs are known to play a crucial role in gut health and overall metabolic function. A related study highlighted in PubMed demonstrated that whole-grain wheat consumption exerts a prebiotic effect on the human gut microbiota, increasing levels of beneficial bacteria like bifidobacteria and lactobacilli.

The study also measured metabolic markers. Both diets resulted in significant reductions in lipid levels and improvements in insulin sensitivity. However, the HPWL diet led to a greater decrease in HOMA-β, a measure of pancreatic beta-cell function, while the HFWL diet showed a more favorable impact on glucose levels. Resting metabolic rate (RMR) decreased after both weight loss diets compared to the maintenance diet, and the thermic effect of food (TEF) was lower with the HFWL diet.

Researchers noted that the study cohort was predominantly male, with an average age of 57.4 years and a body mass index of 33.3 kg/m², which may limit the generalizability of the findings. The study, as published in news-medical.net, focused on short-term effects and further research is needed to determine the long-term sustainability and health implications of these dietary approaches.

The findings suggest that tailoring breakfast composition within a calorie-restricted diet could be a valuable strategy for weight management and improving metabolic health. The choice between a high-protein or high-fiber breakfast may depend on individual goals, with the HPWL diet potentially offering greater satiety for long-term adherence and the HFWL diet promoting a more beneficial gut microbiota profile.

February 16, 2026 0 comments