NCT06891287

An Early Phase Study of RT-114 (RaniPill Containing PG-102, a GLP-1/2 Dual Agonist) in Healthy Volunteers.

A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RT-114 in Healthy Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: RANI Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this Phase 1 study is to evaluate the safety and tolerability of RT-114 in healthy volunteers. The main objectives are: Primary: To evaluate safety and tolerability of RT-114 when administered as single and multiple doses by assessing treatment emergent adverse events (TEAEs) in healthy volunteers Secondary: * To determine the pharmacokinetics of RT-114 administered as single and multiple doses * To determine the pharmacodynamic effects of RT-114 administered as multiple doses In the single dose portion of the study participants will either receive the drug via a subcutaneous injection or an oral pill (RT-114). In the repeat dose portion of the study participants will randomized to either RT-114 or a placebo.

Conditions

• Obesity

Interventions

Type	Name	Description
COMBINATION_PRODUCT	RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity	RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity.
DRUG	PG-102	PG-102 is a drug for the treatment of obesity.
OTHER	Placebo	The placebo is the RaniPill with saline instead of a drug.

Timeline

• Start date: 2025-12-30
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-03-24
• Last updated: 2026-04-14

Locations

1 site across 1 country: Australia