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

NCT06891287 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • RANI Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2026-12-01
Completion
2027-06-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06891287 on ClinicalTrials.gov