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

NCT06891287 | Recruiting Phase 1

• 1 other identifier: RT-114-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• To evaluate safety and tolerability of RT-114 by assessing treatment emergent adverse events (TEAEs)

  Single dose and 8 weeks of repeat dosing

Secondary Outcomes (7)

• To determine the pharmacokinetics of RT-114

  Single dose and 8 weeks of repeat dosing

• To determine the pharmacokinetics of RT-114

  Single dose and 8 weeks of repeat dosing

• To determine the pharmacokinetics of RT-114

  Single dose and 8 weeks of repeat dosing

• To determine the pharmacodynamic effects of RT-114

  Single dose and 8 weeks of repeat dose

• To determine the pharmacodynamic effects of RT-114

  Single dose and 8 weeks of repeat dose

Study Arms (4)

Group A1 - Subcutaneous injection control

ACTIVE COMPARATOR

Drug: PG-102

Group A2 - RT-114

EXPERIMENTAL

Combination Product: RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity

Group B1 - Placebo

PLACEBO COMPARATOR

Other: Placebo

Group B2 - RT-114

EXPERIMENTAL

Combination Product: RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity

Interventions

PG-102 DRUG

PG-102 is a drug for the treatment of obesity.

Group A1 - Subcutaneous injection control

Placebo OTHER

The placebo is the RaniPill with saline instead of a drug.

Group B1 - Placebo

RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity COMBINATION_PRODUCT

RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity.

Group A2 - RT-114; Group B2 - RT-114

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• RANI Therapeutics: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arvinder Dhalla, PhD

CONTACT

(408) 457-3700; arvinder@ranitherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A is open label and Part B is randomized, double blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 24, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)