ObesityPhase 1NCT06891287
An Early Phase Study of RT-114 (RaniPill Containing PG-102, a GLP-1/2 Dual Agonist) in Healthy Volunteers.
A Phase 1 study testing RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity and PG-102 in people with Obesity, run by RANI Therapeutics at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity and PG-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Dec 2025to 1 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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
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- 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
Who cannot join
- 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.
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- 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.
- 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% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]) within 12 weeks prior to the screening visit.
- 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 per μL) or an international normalized ratio higher than 1.5.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RT-114 in Healthy Volunteers
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
Read more
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
- Being tested
- RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity, PG-102, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-114 is the RaniPill capsule with PG-102 for the treatment of obesityCombination product
RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity.
PG-102Drug
PG-102 is a drug for the treatment of obesity.
PlaceboOther
The placebo is the RaniPill with saline instead of a drug.
| Study group | Role | What they receive |
|---|---|---|
| Group A1 - Subcutaneous injection control | Active comparator | Not described Receives: Drug: PG-102 |
| Group A2 - RT-114 | Experimental | Not described Receives: Combination Product: RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity |
| Group B1 - Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Group B2 - RT-114 | Experimental | Not described Receives: Combination Product: RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability of RT-114 by assessing treatment emergent adverse events (TEAEs)
Measured: Single dose and 8 weeks of repeat dosing
Secondary outcomes (7)
To determine the pharmacokinetics of RT-114
Peak Plasma Concentration (Cmax)
Measured: Single dose and 8 weeks of repeat dosing
To determine the pharmacokinetics of RT-114
Area under the plasma concentration versus time curve (AUC)
Measured: Single dose and 8 weeks of repeat dosing
To determine the pharmacokinetics of RT-114
Time to peak drug concentration (Tmax)
Measured: Single dose and 8 weeks of repeat dosing
To determine the pharmacodynamic effects of RT-114
Body weight
Measured: Single dose and 8 weeks of repeat dose
To determine the pharmacodynamic effects of RT-114
Body mass index (BMI)
Measured: Single dose and 8 weeks of repeat dose
To determine the pharmacodynamic effects of RT-114
Waist circumference measurement
Measured: Single dose and 8 weeks of repeat dose
To determine the pharmacodynamic effects of RT-114
Waist-hip ratio
Measured: Single dose and 8 weeks of repeat dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start30 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RANI Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891287
- Sponsor's protocol ID
- RT-114-001
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not necessary to share the IPD with others but can be shared if asked for a specific reason or to substantiate validity of the learnings of the study
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RT-114 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06891287
- Acronym / sponsor ID
- RT-114-001
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RANI TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant is ambulatory and between 18 to 65 years of age
- Body mass index between:
- 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
Key exclusion criteria (42 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-114 is the RaniPill capsule with PG-102 for the treatment of obesityRT-114 is the RaniPill capsule with PG-102 for the treatment of obesity. | Combination product | Group A2 - RT-114, Group B2 - RT-114 |
| PG-102PG-102 is a drug for the treatment of obesity. | Drug | Group A1 - Subcutaneous injection control |
| PlaceboThe placebo is the RaniPill with saline instead of a drug. | Other | Group B1 - Placebo |
Primary outcome
To evaluate safety and tolerability of RT-114 by assessing treatment emergent adverse events (TEAEs)
Time frame: Single dose and 8 weeks of repeat dosing
7 secondary outcomes
To determine the pharmacokinetics of RT-114
Time frame: Single dose and 8 weeks of repeat dosing
To determine the pharmacokinetics of RT-114
Time frame: Single dose and 8 weeks of repeat dosing
To determine the pharmacokinetics of RT-114
Time frame: Single dose and 8 weeks of repeat dosing
To determine the pharmacodynamic effects of RT-114
Time frame: Single dose and 8 weeks of repeat dose
To determine the pharmacodynamic effects of RT-114
Time frame: Single dose and 8 weeks of repeat dose
To determine the pharmacodynamic effects of RT-114
Time frame: Single dose and 8 weeks of repeat dose
To determine the pharmacodynamic effects of RT-114
Time frame: Single dose and 8 weeks of repeat dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. It is not necessary to share the IPD with others but can be shared if asked for a specific reason or to substantiate validity of the learnings of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity and PG-102 in people with Obesity, run by RANI Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arvinder Dhalla, PhD ((408) 457-3700, arvinder@ranitherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety and tolerability of RT-114 by assessing treatment emergent adverse events (TEAEs) (time frame: Single dose and 8 weeks of repeat dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.