All articles tagged with #clinical trial
A 104-person study (aged 65–75) found that four weeks of dietary changes, especially plant-forward diets with about 70% plant protein, lowered biological age as judged by 20 health biomarkers in three of four diet groups; a high-fat omnivorous diet showed no meaningful change. The results suggest short-term dietary shifts can affect aging biomarkers, but are preliminary.
A four-week proof-of-concept trial in 30 adults with major depressive disorder and signs of inflammation tested the IL-6 receptor blocker tocilizumab. Treated participants showed greater improvements in depressive symptoms, fatigue, anxiety, and quality of life than placebo, with remission rates around 54% vs 31%, but the study was not powered for statistical significance. The researchers highlighted that those with higher baseline inflammation tended to respond best, suggesting inflammation-targeted therapies merit larger, longer trials. No notable adverse effects were reported.
Biogen and Denali Therapeutics' experimental Parkinson’s drug targeting the LRRK2 protein did not slow disease progression in a large randomized trial, delivering a setback to the idea that LRRK2 blockade could benefit all patients with Parkinson’s disease.
Eli Lilly announced topline TRIUMPH-1 results for retatrutide, a first-in-class GIP/GLP-1/glucagon triple agonist, in adults with obesity or overweight and comorbidities. Across 4 mg, 9 mg, and 12 mg doses, participants achieved meaningful weight loss at 80 weeks (4 mg: 19.0%, 9 mg: 25.9%, 12 mg: 28.3%), with the 12 mg group averaging 70.3 lb and 45.3% reaching ≥30% weight loss; BMI ≤22 was achieved by 65.3% at Week 80. Some participants with higher BMI continued losing weight in extensions, reaching about 30% total body weight loss over roughly two years. All arms met primary and key secondary endpoints, and the follow-on extension data covered up to 104 weeks. Safety disclosures mirror warnings associated with Lilly's obesity medicines.
Lilly reports that retatrutide, a triple agonist of GLP-1, GIP, and glucagon, produced up to about 85 pounds (roughly 30% of body weight) loss in a phase 3 trial of ~2,300 people with obesity or overweight, with the highest weekly dose averaging 28% weight loss over 80 weeks (some participants continued to 104 weeks). If approved, it could surpass current GLP-1 meds and aid patients who don’t respond to those drugs. Side effects include nausea, GI issues, skin sensations, and UTIs. Full results haven’t been published in a medical journal, and an FDA filing could occur as early as this year.
A small Bristol randomized trial suggests the anti-inflammatory drug tocilizumab, which blocks IL-6R, may benefit people with treatment-resistant depression. Those given the drug showed greater improvement across measures and higher remission rates (54% vs 31%) with a number needed to treat of 5, though the small sample size means results are preliminary and require confirmation in larger studies; this points to a potential new, tailored immunotherapy approach for patients not responding to standard antidepressants.
A randomized JAMA Network Open trial found that a single psilocybin dose, paired with psychotherapy, increased cocaine abstinence versus placebo among 36 participants, highlighting a potential new treatment since there are no FDA-approved cocaine-use meds. Experts say psilocybin may act as a catalyst for behavioral change via neuroplasticity, not as a maintenance drug. However, the small size, specific exclusions (no comorbid depression/anxiety), and recruitment nuances limit generalizability, and larger trials are needed. Notably, the study included a majority of Black participants, a first for psychedelic trials.
A new daily pill, orforglipron, could help people maintain weight loss after stopping GLP-1 obesity injections. In a Nature Medicine trial, participants who took orforglipron for a year kept more than 70% of their earlier weight loss, versus about 38-50% for those on placebo; side effects were mostly mild. The long-term durability, duration of treatment, and cost (UK pricing not yet known) remain unclear, but experts say this supports the view that obesity is a chronic condition requiring ongoing management.
Mercy Health’s Springfield and Urbana Cancer Centers have begun the IMPACT clinical trial testing the Lilac Glove & Boot, a device that gently compresses the hands and feet during chemotherapy to potentially reduce chemotherapy‑induced peripheral neuropathy, a nerve‑damage side effect that can cause numbness, tingling, pain and impaired daily activities. Participants will use either the active device or a comparator and be closely monitored to help determine if this approach preserves function and quality of life for central Ohio cancer patients.
A UK-led NEOPRISM-CRC trial treated stage II/III MMR-deficient/MSI-H bowel cancer with up to nine weeks of pembrolizumab before surgery. After ~33 months of follow-up, none of the 32 patients have recurred, and 59% had no detectable cancer at surgery, suggesting preoperative immunotherapy may provide durable control compared with standard surgery followed by chemotherapy. Researchers are also using personalized blood tests and immune profiling to predict responders and monitor remaining disease.
A New England Journal of Medicine analysis of Canadian and UK trials (about 4,200 participants) found Paxlovid does not reduce hospitalizations or death in a largely vaccinated population, though users recovered about three days faster; the results could influence how public funding and prescriptions are targeted for antivirals.
Veradermics’ oral minoxidil candidate VDPHL01 posted positive Phase II/III results for mild-to-moderate pattern hair loss, with 79% (single-dose 8.5 mg daily) and 86% (twice-daily) showing significant hair growth versus 36% on placebo, and a safety profile similar to placebo. If approved, it would be the first new oral treatment for pattern baldness in about 30 years, offering a non-hormonal option with an extended-release design to minimize cardiovascular risks.
In the ALASCCA randomized trial across 33 hospitals, daily 160 mg aspirin after colorectal cancer surgery reduced recurrence by about half for patients with PI3K pathway mutations or related alterations (7.7% vs 14.1% and 7.7% vs 16.8%), with improved 3-year disease-free survival (~89% vs 79–81%), but higher severe side effects (16.8% vs 11.6%), suggesting a low-cost, genetics-driven post-surgical option pending guidelines.
A breast cancer survivor at Stony Brook University Hospital participates in a global clinical trial of an experimental tumor vaccine aimed at reducing recurrence risk, reflecting ongoing efforts to improve prevention after initial treatment.
In the largest trial to date, a gene therapy delivering functional copies of the OTOF gene to the inner ear improved hearing in about 90% of participants (38 of 42) with congenital deafness caused by OTOF mutations, across eight sites in China. Improvements began within weeks and persisted for up to two years in many cases; some participants achieved normal conversational hearing, while a few showed no benefit. The therapy had no serious side effects, though some mild vertigo or inner-ear inflammation occurred, and younger patients tended to improve more. If further trials confirm long-term safety and broader applicability, the approach could offer a one‑and‑done alternative or complement to cochlear implants, with next steps including longer follow-up and dosing studies.