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New treatment option for Obesity
Official title An Early Phase Study of RT-114 (RaniPill Containing PG-102, a GLP-1/2 Dual Agonist) in Healthy Volunteers.
ClinicalTrials.gov ID: NCT06891287
What this study is testing
What is 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 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Participant is ambulatory and between 18 to 65 years of age
- Body mass index between:
- Part A: 19 - 32 kg/m2
- Part B: \>30 kg/m2
- Female volunteers must be non-pregnant or non-lactating during study participation
You likely can't join if
- History of intolerance to study drug (i.e., allergy to PG-102 or excipients).
- HbA1c ≥ 6.5% at screening.
- Treated with GLP-1 or GLP-2 agonist, or similar drugs, within 90 days prior to screening.
- History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding, etc.) or gastrointestinal procedures for...
- Total cholesterol \>10.3 mmol/L or triglycerides ≥5.7 mmol/L (500 mg/dL) at screening.
- Experienced a \>5% loss in body weight within 2 months prior to screening.
See the full eligibility criteria
Who can join
- Participant is ambulatory and between 18 to 65 years of age
- Body mass index between:
- Part A: 19 - 32 kg/m2
- Part B: \>30 kg/m2
- Female volunteers must be non-pregnant or non-lactating during study participation
- Male volunteers must agree to use acceptable forms of contraception, if necessary, and to not donate sperm during study participation
- Have suitable venous access for blood sampling
- In good general health confirmed by medical history, physical examination, and absence of clinically important laboratory abnormalities per Investigator's judgment
- Participant understands the nature of the study, is willing to comply with protocol defined evaluations, and provide written informed consent
What rules you out
- History of intolerance to study drug (i.e., allergy to PG-102 or excipients).
- HbA1c ≥ 6.5% at screening.
- Treated with GLP-1 or GLP-2 agonist, or similar drugs, within 90 days prior to screening.
- History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding, etc.) or gastrointestinal procedures for weight loss (including LAP-BAND®).
- Total cholesterol \>10.3 mmol/L or triglycerides ≥5.7 mmol/L (500 mg/dL) at screening.
- Experienced a \>5% loss in body weight within 2 months prior to screening.
- History (≤10 years) or presence of disease determined by the PI to be clinically significant including:
- gastrointestinal/digestive (including diverticulitis, gastroparesis, stomach ulcers, inflammatory intestinal disease, gastrointestinal perforations/fistulae/intra-abdominal abscess, abnormal or irregular bowel movements)
- any other internal, non-gastrointestinal fistulae that is at an increased risk of bleeding
- hematological (including pancytopenia, aplastic anemia, or blood dyscrasia)
- proliferative retinopathy or maculopathy
- allergic disease excluding mild asymptomatic seasonal and food allergies
- renal, endocrine, hepatic, pulmonary (childhood asthma is allowed), neurologic, psychiatric, metabolic (including known diabetes mellitus)
- Have a history of prolonged immunosuppressant therapy or photochemotherapy treatment.
- Have a history of and/or current cardiac disease defined as one of the following:
- History of congestive heart failure; angina pectoris requiring anti-anginal medication.
- History of transmural infarction on ECG, if ECG results are available.
- History of sustained hypertension (systolic \> 180 mmHg and/or diastolic \> 100 mmHg), hypertensive crisis or hypertension encephalopathy.
- Clinically significant valvular heart disease, severe arterial thromboembolic events, or venous thromboembolic events.
- Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, human immunodeficiency virus (HIV) or history of active, latent, or inadequately treated tuberculosis (TB) infection.
- Positive serum pregnancy test for women of childbearing potential at the Screening visit or positive urine pregnancy test with confirmatory serum pregnancy test prior to dosing.
- Females who are breastfeeding.
- Have a history of cancer including lymphoma, leukemia, and skin cancer (volunteers with a maximum of 3 surgically resected basal cell carcinoma or squamous cell carcinoma are permitted).
- Any current active infections, including localized infections, or any recent history (within 1 week prior to study drug administration) of active infections (including severe acute respiratory syndrome coronavirus 2...
- Have had major surgery within 30 days prior to screening or will have an operation between screening and the end of study visit, or have any unhealed wound, including wound dehiscence and wound healing complications...
- Have received live vaccines during the past 4 weeks before Screening or have the intention to receive vaccination during the study period or within 13 weeks after dosing.
- Have received a Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to dose administration or is planning to receive a BCG vaccination within 1 year following dose administration.
- History of alcohol abuse (defined as more than 14 standard drinks per week or more than 4 standard drinks on \> 3 days per week; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9%...
- Excessive smoking habit (more than 5 cigarettes/day).
- Positive drug or alcohol test results. In the event the urinary drug test is positive, the test may be repeated once (at the discretion of the PI) to confirm eligibility.
- Consumption of any food containing poppy seeds within 48 hours prior to screening and admission to the clinical center.
- Donation of more than 500 mL of blood within 4 weeks prior to drug administration.
- Any history of non-traumatic hemorrhage (i.e., any hemorrhage requiring medical intervention) or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia (platelet count \< 150,000...
- Impaired liver function as determined by a serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 1.5 x upper limit of normal (ULN). Participants with values between ULN and 1.5 x ULN may be...
- Treatment with non-topical medications (including over-the-counter [OTC] medications and herbal remedies such as St. John's Wort extract) within 7 days or 5 half-lives of the drug (whichever is longer) prior to CTM...
- Participants on a higher than the lowest approved therapeutic dose regimen of proton pump inhibitors (see Section 9.1.7 for details).
- Participants on a H2 receptor antagonists (e.g., famotidine, cimetidine).
- History of proteinuria (other than trace amounts i.e., +, ++/+++).
- Other clinically relevant findings per physical or laboratory examination or symptoms of a clinically relevant illness 3 weeks prior to the dose of study drug.
- Participation in a clinical study with an investigational product (IP) dosing within 60 days or 5 half-lives of that IP (if known), whichever is longer, prior to IP administration in the current study.
- History which, in the Investigator's judgement, makes the participant ineligible or exposes the participant to unacceptable risks.
- Low likelihood, in the Investigator's judgment, to complete the study as required per study plan.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.