An Early Phase Study of RT-114 (RaniPill Containing PG-102, a GLP-1/2 Dual Agonist) in Hea
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
| Condition(s) | Obesity |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Participant is ambulatory and between 18 to 65 years of age 2. Body mass index between: 1. Part A: 19 - 32 kg/m2 2. Part B: \>30 kg/m2 3. Female volunteers must be non-pregnant or non-lactating during study participation 4. Male volunteers must agree to use acceptable forms of contraception, if necessary, and to not donate sperm during study participation 5. Have suitable venous access for blood sampling 6. In good general health confirmed by medical history, physical examination, and absence of clinically important laboratory abnormalities per Investigator's judgment 7. Participant understands the nature of the study, is willing to comply with protocol defined evaluations, and provide written informed consent Exclusion Criteria: 1. History of intolerance to study dr |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | RANI Therapeutics |
| Locations | Melbourne, Victoria, Australia |
| Start date | 2025-12-30 |
| NCT ID | NCT06891287 |
| Official listing | https://clinicaltrials.gov/study/NCT06891287 |