Obesity &Amp; Overweight
Conditions
Keywords
obesity, overweight, healthy volunteers
Brief summary
Study to assess the safety, pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body) of RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects)
Interventions
DRUGRN3161
Investigational Product
DRUGPlacebo Control
0.9% normal saline SC injection
DRUGTirzepatide
In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide
Sponsors
Shanghai Rona Therapeutics Co., Ltd.
Ikaria Bioscience Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
randomized to study drug or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI: Obesity: BMI ≥ 30 kg/m² for participants with no Asian ancestry and ≥ 27.5 kg/m² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with or without a weight-related comorbidity (excluding diabetes) Overweight: BMI 27 to \<30 kg/m² for participants with no Asian ancestry and 23.0 to \<27.5 kg/m² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with at least 1 weight-related comorbidity (excluding diabetes) Weight-related comorbidities include a diagnosis of the following: * Hypertension: seated BP ≤ 140/90 mm Hg; receiving ≤ 2 stable (≥ 4 weeks) agents limited to ACE inhibitors, angiotensin receptor blockers, calcium channel blockers, or thiazide ≤ 25 mg, or untreated * Dyslipidemia: stable use of lipid-lowering agents for dyslipidemia (LDL-C \< 150 mg/dL, triglycerides \< 300 mg/dL) * Osteoarthritis
Exclusion criteria
* self-reported or documented weight gain or loss \>5% within 3 months prior to screening * use of GLP1R agonists within 6 months of screening * intolerance to GLP-1 medications in the past * use of non-GLP1R medications for weight loss within 3 months of screening * HbA1c \>6.5% * diagnosis of significant liver disease * history of malignancy or anaphylaxis * use of any siRNA agent in the prior 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Coagulation Laboratory | 180 days | Number of participants with changes in plasma prothrombin time, activated partial thromboplastin time, and international normalized ratio measured in standard units |
| Physical Examination | 180 days | Number of participants with changes seen by physical examination of skin, lymph nodes, eyes, ears, throat, chest, abdomen, musculoskeletal system and nervous system |
| Blood Chemistry Laboratory | 180 days | Number of participants with changes in blood levels of sodium, potassium, chloride, calcium magnesium, creatinine, bilirubin, phosphate, AST, ALT, alkaline phosphatase, glucose, albumin, urea in standard units |
| Adverse Events | 180 days | Incidence of adverse events reported |
| Heart Rate | 180 days | Number of participants with change in heart rate measured in beats per minute |
| ECG QRS Complex | 180 days | Number of participants with changes in QRS complex measured in milliseconds |
| ECG QT interval | 180 days | Number of participants with change in QT interval measured by Frederica method in milliseconds |
| Blood Hematology Laboratory | 180 days | Number of participants with changes in blood hemoglobin, hematocrit, platelets, neutrophils and leukocytes measured in standard units |
| Blood Pressure | 180 Days | Number of participants with blood pressure changes measured in mmHg |
| ECG PR interval | 180 days | Number of participants with change in PR interval measured as milliseconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of ADA | 180 days | incidence of anti-drug antibodies in the plasma |
| Plasma and Urine Pharmacokinetics | 180 Days | plasma and urine levels of RN3161 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of RN3161 on plasma total cholesterol | 180 days | total cholesterol in mg/dL |
| Assess RN3161 effect on plasma LDL | 180 days | LDL-C in mg/dL |
| Effect of RN3161 on plasma insulin | 180 days | assess plasma insulin uU/mL |
| Effect of RN3161 on plasma triglycerides | 180 days | triglycerides in mg/dL |
| Effect of RN3161 on plasma HDL | 180 days | HDL in mg/dL |
Countries
Australia
Outcome results
None listed