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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

An Early Phase Study of RT-114 (RaniPill Containing PG-102, a GLP-1/2 Dual Agonist) in Healthy Volunteers. (NCT06891287) is a Phase 1 interventional studying Obesity, sponsored by RANI Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Obesity, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Obesity subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form Who Should NOT Join This Trial: 1. History of intolerance to study drug (i.e., allergy to PG-102 or excipients). 2. HbA1c ≥ 6.5% at screening. 3. Treated with GLP-1 or GLP-2 agonist, or similar drugs, within 90 days prior to screening. 4. History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding, etc.) or gastrointestinal procedures for weight loss (including LAP-BAND®). 5. Total cholesterol \>10.3 mmol/L or triglycerides ≥5.7 mmol/L (500 mg/dL) at screening. 6. Experienced a \>5% loss in body weight within 2 months prior to screening. 7. History (≤10 years) or presence of disease determined by the PI to be clinically significant including: 1. gastrointestinal/digestive (including diverticulitis, gastroparesis, stomach ulcers, inflammatory intestinal disease, gastrointestinal perforations/fistulae/intra-abdominal abscess, abnormal or irregular bowel movements) 2. any other internal, non-gastrointestinal fistulae that is at an increased risk of bleeding 3. hematological (including pancytopenia, aplastic anemia, or blood dyscrasia) 4. proliferative retinopathy or maculopathy 5. allergic disease excluding mild asymptomatic seasonal and food allergies ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 drug (i.e., allergy to PG-102 or excipients). 2. HbA1c ≥ 6.5% at screening. 3. Treated with GLP-1 or GLP-2 agonist, or similar drugs, within 90 days prior to screening. 4. History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding, etc.) or gastrointestinal procedures for weight loss (including LAP-BAND®). 5. Total cholesterol \>10.3 mmol/L or triglycerides ≥5.7 mmol/L (500 mg/dL) at screening. 6. Experienced a \>5% loss in body weight within 2 months prior to screening. 7. History (≤10 years) or presence of disease determined by the PI to be clinically significant including: 1. gastrointestinal/digestive (including diverticulitis, gastroparesis, stomach ulcers, inflammatory intestinal disease, gastrointestinal perforations/fistulae/intra-abdominal abscess, abnormal or irregular bowel movements) 2. any other internal, non-gastrointestinal fistulae that is at an increased risk of bleeding 3. hematological (including pancytopenia, aplastic anemia, or blood dyscrasia) 4. proliferative retinopathy or maculopathy 5. allergic disease excluding mild asymptomatic seasonal and food allergies 6. renal, endocrine, hepatic, pulmonary (childhood asthma is allowed), neurologic, psychiatric, metabolic (including known diabetes mellitus) 8. Have a history of prolonged immunosuppressant therapy or photochemotherapy treatment. 9. Have a history of and/or current cardiac disease defined as one of the following: 1. History of congestive heart failure; angina pectoris requiring anti-anginal medication. 2. History of transmural infarction on ECG, if ECG results are available. 3. History of sustained hypertension (systolic \> 180 mmHg and/or diastolic \> 100 mmHg), hypertensive crisis or hypertension encephalopathy. 4. Clinically significant valvular heart disease, severe arterial thromboembolic events, or venous thromboembolic events. 10. 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. 11. 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. 12. Females who are breastfeeding. 13. 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). 14. 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 \[SARS-CoV-2\] based on a positive COVID-19 polymerase chain reaction \[PCR\] nasopharyngeal swab test), cough or fever, or a history of recurrent or chronic infections. 15. 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 requiring medical intervention. 16. 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. 17. 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. 18. 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 \[4.9% Alc./Vol\], 100 mL wine \[12% Alc./Vol\], 30 mL spirit \[40% Alc./Vol\]) within 12 weeks prior to the screening visit. 19. Excessive smoking habit (more than 5 cigarettes/day). 20. 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. 21. Consumption of any food containing poppy seeds within 48 hours prior to screening and admission to the clinical center. 22. Donation of more than 500 mL of blood within 4 weeks prior to drug administration. 23. 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 per μL) or an international normalized ratio higher than 1.5. 24. 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 included in the study if considered not clinically significant by the Investigator. 25. 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 administration, with the exception of birth control medications, multivitamins, vitamin C, food supplements and a limited amount of acetaminophen (up to 2 g in 24 hours, but \<1 g in 4 hours) or ibuprofen (\<1.2 g per day), which may be used throughout the study. 26. Participants on a higher than the lowest approved therapeutic dose regimen of proton pump inhibitors (see Section 9.1.7 for details). 27. Participants on a H2 receptor antagonists (e.g., famotidine, cimetidine). 28. History of proteinuria (other than trace amounts i.e., +, ++/+++). 29. 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. 30. 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. 31. History which, in the Investigator's judgement, makes the participant ineligible or exposes the participant to unacceptable risks. 32. Low likelihood, in the Investigator's judgment, to complete the study as required per study plan.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Nucleus Network
Melbourne, Victoria, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06891287), the sponsor (RANI Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06891287 clinical trial studying?

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 i… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06891287?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06891287?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06891287. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06891287. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.