Rani Therapeutics has reported positive initial Phase 1a data for its investigational oral obesity therapy RT-114, with the company saying the treatment achieved greater systemic exposure than a matched subcutaneous dose while demonstrating a favourable safety profile.

RT-114 uses Rani’s oral capsule technology to deliver PG-102, a GLP-1/GLP-2 dual agonist being developed with ProGen for the treatment of obesity.

The ongoing open-label Phase 1a study is comparing the safety, tolerability, pharmacokinetics and bioavailability of orally administered RT-114 with subcutaneous PG-102 in healthy volunteers.

Thirty participants were randomised to receive a single 12 mg dose of PG-102 either orally using the RaniPill capsule or by subcutaneous injection.

According to the company, oral RT-114 achieved systemic exposure exceeding 150% of the matched subcutaneous dose. The elimination half-life was similar between the two treatment groups, measuring 5.6 days following oral administration compared with 5.3 days for subcutaneous dosing.

No serious adverse events were reported during the study and no adverse events were attributed to the capsule itself. Treatment-related adverse events, including nausea, vomiting and diarrhoea, were reported as mild and consistent with the known safety profile of GLP-1/GLP-2 agonists.

Talat Imran, chief executive officer of Rani Therapeutics, said: “The safety and bioavailability findings reported today exceeded our expectations and represent an important milestone for the RaniPill platform. We have previously demonstrated that the RaniPill can orally deliver a broad range of biologics across multiple therapeutic areas. With RT-114, we have now extended that capability into obesity and metabolic disease while achieving systemic exposure well above that of the matched subcutaneous dose.”

The company is now expanding the Phase 1a study with an additional cohort of 15 healthy volunteers to further evaluate the relationship between oral and subcutaneous dosing.

Participants in the new cohort will receive two separate 12 mg doses of PG-102 via the oral capsule, with the findings expected to inform dose selection for the planned Phase 1b study.

The Phase 1b trial will evaluate eight weeks of repeat dosing with RT-114 in patients with obesity. Rani expects the study to begin later in 2026, with data anticipated in 2027.

RT-114 is being developed under a collaboration agreement between Rani Therapeutics and ProGen, with both companies sharing development costs and future commercialisation responsibilities.