Rani Therapeutics initiates phase 1 study of RT-114 RaniPill

Rani Therapeutics has initiated a Phase 1 clinical trial to evaluate the safety, tolerability, bioavailability and pharmacokinetics and pharmacodynamics of single and multiple doses of RT-114, an orally administered RaniPill capsule containing a GLP-1/GLP-2 dual agonist, PG-102, for the treatment of obesity.

RaniPill

PG-102 is a fc-fusion protein conjugated GLP-1/GLP-2 dual agonist in development by ProGen, which recently announced preclinical and clinical data, at the 2025 European Association for the Study of Diabetes (EASD) meeting, demonstrating glucose-lowering effects and meaningful early weight-loss signals by PG-102, reinforcing its potential as a next-generation metabolic therapy.

In preclinical testing of RT-114 in animal models, the RaniPill delivered PG-102 orally with bioavailability, pharmacokinetics, and weight loss comparable to subcutaneous (SC) injection.

RT-114 is the subject of a Collaboration Agreement between Rani and ProGen entered into in June 2024. Under the Collaboration Agreement, Rani and ProGen will collaborate to manufacture, develop, seek regulatory approvals for and, if approved, commercialise RT-114 in the field of weight management (including without limitation obesity, weight reduction and weight maintenance) in humans.

Under the Collaboration Agreement, development costs, as well as operating profits and losses from the commercialisation of RT-114, will be equally shared by Rani and ProGen. The parties share responsibility for the development of RT-114 worldwide, with Rani leading such development for preclinical activities through Phase 1 clinical trials. After initiation of the first Phase 2 clinical trial, Rani will lead development and commercialisation of RT-114 in the US, Canada, Europe (including the United Kingdom) and Australia, and ProGen will lead development and commercialisation in all other countries.

“The initiation of Phase 1 trial for RT-114 is an important step towards our vision of making oral biologics a reality,” said Talat Imran, Chief Executive Officer of Rani. “As we initiate this trial and advance RT-114 through clinical development, we view this progress as powerful validation of the modality and the unmet need it addresses. We believe that a tolerable and efficacious oral option has the potential to expand access, improve patient experience, and meaningfully reshape the obesity treatment paradigm.”