Rani Therapeutics Launches Phase 1 Trial of Oral GLP-1/GLP-2 Dual Agonist RT-114 for Obesity Treatment
Key Insights
Rani Therapeutics has initiated a Phase 1 clinical trial evaluating RT-114, an oral RaniPill capsule containing the GLP-1 (search)/GLP-2 (search) dual agonist PG-102 for obesity treatment.
Preclinical testing demonstrated that RT-114 delivered via RaniPill achieved bioavailability, pharmacokinetics, and weight loss comparable to subcutaneous injection in animal models.
The collaboration with ProGen (search) aims to develop an oral alternative to injectable obesity medications, potentially expanding patient access and improving treatment experience.
Rani Therapeutics Holdings, Inc. has announced the initiation of a Phase 1 clinical trial for RT-114, an orally administered RaniPill capsule containing PG-102, a GLP-1 (search)/GLP-2 (search) dual agonist developed for obesity treatment. The study will evaluate the safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics of single and multiple doses of RT-114 compared to subcutaneous injection.
Novel Oral Delivery Platform Shows Promise
The RT-114 capsule utilizes Rani's proprietary RaniPill technology, designed to replace subcutaneous injections with oral dosing for biologics. In preclinical testing conducted in animal models, the RaniPill delivered PG-102 orally with bioavailability, pharmacokinetics, and weight loss outcomes comparable to subcutaneous injection.
"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 Therapeutics. "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."
GLP-1/GLP-2 Dual Agonist Mechanism
PG-102, developed by ProGen (search) Co., Ltd., is an fc-fusion protein conjugated GLP-1 (search)/GLP-2 (search) dual agonist. ProGen recently presented 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, reinforcing PG-102's potential as a next-generation metabolic therapy.
Strategic Collaboration Framework
RT-114 is the subject of a collaboration agreement between Rani and ProGen (search) established in June 2024. Under this partnership, both companies will collaborate on manufacturing, development, regulatory approvals, and potential commercialization of RT-114 for weight management applications, including obesity, weight reduction, and weight maintenance.
The collaboration structure divides responsibilities geographically and by development phase. Rani leads development for preclinical activities through Phase 1 clinical trials globally. Following initiation of the first Phase 2 clinical trial, Rani will lead development and commercialization in the United States, Canada, Europe (including the United Kingdom), and Australia, while ProGen (search) will oversee development and commercialization in all other countries. Development costs and operating profits or losses from RT-114 commercialization will be shared equally between the partners.
Clinical Development Strategy
The Phase 1 trial represents a critical milestone in validating Rani's oral biologics platform technology. The RaniPill capsule is designed as a novel, proprietary, and patented platform technology intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani has previously conducted several preclinical and clinical studies evaluating safety, tolerability, and bioavailability using the RaniPill capsule technology.