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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT06891287

Run by

RANI Therapeutics

People needed

60

Starts

2025-12-30

Expected to finish

2027-06-01

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify 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
• 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

You may not qualify 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 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 [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.
• 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.

Where it is running

• Nucleus Network — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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