Ascletis Secures FDA IND for 13-Week Phase II ASC30 Diabetes Trial
Ascletis received FDA IND clearance for a 13-week Phase II trial of oral GLP-1 candidate ASC30 in type 2 diabetes, evaluating HbA1c change in 100 participants. In a 13-week obesity study, ASC30 achieved placebo-adjusted weight loss of 5.4%, 7.0% and 7.7%, with half the vomiting rate of published GLP-1 trials.
1. Novo Nordisk Launches First Oral GLP-1 Weight-Loss Pill in the U.S.
On January 5, 2026, Novo Nordisk made its once-daily Wegovy® pill broadly available through more than 70,000 U.S. pharmacies and multiple telehealth platforms. The FDA approved the oral semaglutide formulation on December 22, 2025, following the 64-week phase 3 OASIS 4 trial in 307 adults with obesity or overweight. In that study, participants who remained on the 25 mg dose achieved an average weight reduction of 16.6%, compared with 2.7% for placebo; when accounting for all randomized patients regardless of adherence, the pill group lost 13.6% versus 2.4% with placebo. Novo Nordisk has set a $149/month self-pay price for the 1.5 mg starter dose, with higher doses priced at $149–$299/month through April 15, before adjustments to $199–$299/month thereafter. Commercially insured patients may pay as little as $25/month under the company’s savings offer.
2. Weight Watchers Integrates Oral GLP-1 into Its Med+ Care Model
WW International announced that its NovoCare® Recognized Care Provider status enables Med+ members to access the Wegovy® pill through an integrated program combining board-certified clinicians, behavioral coaching and digital tools. In real-world analyses of Med+ participants prescribed any GLP-1, those who engaged with the GLP-1 Success Program lost on average 61.3% more body weight at one month and 29.1% more weight at 12 months than counterparts without behavioral support. Weight Watchers will offer the oral semaglutide starting dose at $149/month to Med+ members, reinforcing its strategy to pair medication with structured lifestyle interventions to improve adherence and outcomes.
3. RedHill Advances RHB-102 to Address GLP-1–Induced GI Side Effects
RedHill Biopharma is developing RHB-102 (Bekinda®), a once-daily, bimodal extended-release ondansetron tablet, as a remedy for nausea, vomiting and diarrhea associated with GLP-1/GIP receptor agonist therapies. Supported by positive U.S. phase 3 gastroenteritis and phase 2 IBS-D data published in JAMA Network Open and The American Journal of Gastroenterology, the company plans a 505(b)(2) phase 2 proof-of-concept trial in early 2026. With over 2% of Americans on GLP-1 agonists but up to 50% discontinuing within three months primarily due to GI intolerance, RedHill projects that improving titration success could recapture as much as $35 billion in lost market value by 2030.
4. Ascletis Receives FDA IND for Oral Small-Molecule GLP-1 in Type 2 Diabetes
Ascletis Pharma secured FDA clearance to initiate a 13-week, randomized, double-blind, placebo-controlled phase 2 trial of ASC30, its oral small-molecule GLP-1 receptor agonist, in approximately 100 adults with type 2 diabetes. The study will evaluate changes in HbA1c, fasting glucose and body weight across three ascending dose cohorts (40 mg, 60 mg and 80 mg) versus placebo, with weekly titration to target doses. Earlier U.S. phase 2 data in obesity showed placebo-adjusted weight reductions of 5.4%, 7.0% and 7.7% at 20 mg, 40 mg and 60 mg, respectively, with gastrointestinal tolerability comparable to competitor oral GLP-1s and no hepatic safety signals observed.