Actively Recruiting
An Early Phase Study of RT-114 (RaniPill Containing PG-102, a GLP-1/2 Dual Agonist) in Healthy Volunteers.
Led by RANI Therapeutics · Updated on 2026-04-14
60
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
An Early Phase Study of RT-114 (RaniPill Containing PG-102, a GLP-1/2 Dual Agonist) in Healthy Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is ambulatory and between 18 to 65 years of age
- Body mass index between 19 to 32 kg/m2 for Part A, or greater than 30 kg/m2 for Part B
- Female volunteers must be non-pregnant and non-lactating during study participation
- Male volunteers must agree to use acceptable contraception if necessary and not donate sperm during the study
- Have suitable venous access for blood sampling
- In good general health confirmed by medical history, physical exam, and no significant lab abnormalities
- Understand the study and willing to comply with evaluations and provide informed consent
You will not qualify if you...
- History of intolerance or allergy to PG-102 or its ingredients
- HbA1c 6.5% or higher at screening
- Treated with GLP-1 or GLP-2 agonists or similar drugs within 90 days prior to screening
- History of obesity surgery or gastrointestinal procedures for weight loss within 2 years
- Total cholesterol above 10.3 mmol/L or triglycerides above 5.7 mmol/L at screening
- Lost more than 5% body weight within 2 months prior to screening
- History or presence of significant diseases including gastrointestinal, hematological, retinal, allergic, renal, endocrine, hepatic, pulmonary (except childhood asthma), neurologic, psychiatric, or metabolic conditions
- History of prolonged immunosuppressant or photochemotherapy treatment
- History or current cardiac disease including heart failure, angina, infarction, severe hypertension, or thromboembolic events
- Positive test for hepatitis B, hepatitis C, HIV, or history of active or latent tuberculosis
- Positive pregnancy test or breastfeeding
- History of cancer except limited skin cancers
- Current or recent active infections including COVID-19
- Major surgery within 30 days prior or planned during the study
- Recent live vaccinations or plans for vaccination during or shortly after the study
- History of alcohol abuse or excessive smoking
- Positive drug or alcohol tests
- Consumption of poppy seeds within 48 hours before screening
- Recent blood donation exceeding 500 mL within 4 weeks
- History of bleeding disorders or conditions increasing bleeding risk
- Impaired liver function beyond defined limits
- Recent treatment with most non-topical medications except some allowed ones
- Use of higher than lowest approved doses of proton pump inhibitors or H2 receptor antagonists
- History of proteinuria beyond trace amounts
- Any other clinically relevant findings or illnesses
- Participation in other clinical studies with investigational products within 60 days
- Any condition or history judged by the investigator to make participation unsafe or unlikely to complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nucleus Network
Melbourne, Victoria, Australia
Actively Recruiting
Research Team
A
Arvinder Dhalla, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here