Rani Therapeutics Holdings, Inc. Class A ((RANI)) announced an update on their ongoing clinical study.
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Rani Therapeutics Holdings, Inc. is conducting a Phase 1 study titled A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RT-114 in Healthy Volunteers. The study aims to assess the safety and tolerability of RT-114, a treatment for obesity, by monitoring treatment emergent adverse events in healthy volunteers. Secondary objectives include evaluating the pharmacokinetics and pharmacodynamics of the drug.
The intervention being tested is RT-114, a combination product delivered via the RaniPill capsule with PG-102, designed to treat obesity. Participants will receive either a subcutaneous injection or an oral pill in the single dose phase, and will be randomized to receive RT-114 or a placebo in the repeat dose phase.
This interventional study is randomized with a parallel assignment model. It employs quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are blinded to the treatment allocation. The primary purpose of the study is treatment.
The study is set to begin on March 7, 2025, with its primary completion and estimated completion dates yet to be determined. The last update was submitted on March 18, 2025, indicating the study is not yet recruiting.
The initiation of this study could influence Rani Therapeutics’ stock performance by potentially boosting investor confidence if the results are positive. The study’s focus on obesity treatment places it in a competitive market, where successful outcomes could position Rani Therapeutics favorably against its peers.
The study is ongoing, and further details are available on the ClinicalTrials portal.