A trial to assess the safety, tolerability and efficacy of RES-010 in overweight and obese adults without obesity-related comorbidities.
A Phase 1b, Randomized, Double-Blinded, Placebo Controlled, MAD Study Evaluating the safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of RES-010 in Overweight and Obese Adults without Obesity-Related Comorbidities.
Resalis Therapeutics Australia Pty Ltd
36 participants
May 28, 2026
Interventional
Conditions
Summary
This is a randomized, placebo-controlled, sequential, multiple ascending dose study conducted at a single site in Australia and comprised of 2 to 3 cohorts (with the third being an optional cohort, at the discretion of the Sponsor). Randomization to either RES-010 or placebo treatment in a ratio of 3 RES-010 to 1 Placebo treatment. An escalating-dose multiple ascending dose study design in overweight and moderately obese participants was chosen to allow careful increase of the study drug RES-010 dose after the assessment of safety, tolerability, and available plasma and urine Pharmacokinetic and Pharmacodynamic results of each preceding dose cohort. A blinded review of all available safety data and plasma and urine Pharmacokinetic and Pharmacodynamic data will be performed by a Safety Review Committee (SRC) after the administration of the fourth study drug dose to identify any potential safety and or tolerability signals. Based on this review the SRC will recommend to either proceed with the study as planned, or indicate if dose escalation or de-escalation is appropriate. If necessary, recruitment may be paused to await the availability of further safety data to make a recommendation. The minimum number of participants required to decide on a dose escalation is 6 participants (at least four participants on active treatment RES-010).
Eligibility
Inclusion Criteria27
- Willing and able to sign an Informed Consent Form (ICF).
- Males and females 18 to 55 years, inclusive, at Screening.
- Overweight or moderately obese participants (Body Mass Index (BMI) of 27.5 to 34.9 kg/m² inclusive) without obesity-related comorbidities at Screening.
- Body Mass Index (BMI) category for cohort balance: Participants will be enrolled to achieve a target of 4 to 8 overweight participants and 4 obese participants within each cohort.
- For this purpose:
- a. Overweight will be classified as: Body Mass Index (BMI) of 27.5 to 29.9 kg/m² at Screening.
- b. Obese (Class I) will be classified as: Body Mass Index (BMI) of 30.0 to 34.9 kg/m² at Screening.
- Body Weight of 50.0 kg or more at Screening.
- Participants must agree to use highly effective contraception such as:
- a. Male participants, if not surgically sterilized or have partners of the same sex, must agree to use highly effective contraception and not plan a pregnancy or donate sperm from Day 1 until 90 days after the last study visit. Highly effective contraception for a male participant (and his female partner, if she is of
- childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of
- contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse up to 90 days after the last study visit, in accordance with the usual lifestyle of the participant, is also acceptable.
- b. Female participants: Female participants of childbearing potential who have a fertile male sexual partners must agree to use highly effective contraception and not to undergo assisted reproductive procedures, including in vitro fertilisation (IVF), oocyte retrieval/collection, or oocyte donation, from Day 1 until 90 days after. Highly effective contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the usual lifestyle of the participant, is also acceptable.
- A resting heart rate between 60 and 100 beats per minute after 5 minutes resting in a supine position.
- The mean value of triplicate measurements of blood pressure at Screening, after resting for 5 minutes in a supine position, must be within the following ranges (unless deemed not clinically significant by the Investigator):
- a) Systolic blood pressure from 90 to 160 mmHg, inclusive.
- b) Diastolic blood pressure from 45 to 100 mmHg, inclusive.
- All prescribed medication must have been/be stopped at least 21 days prior to Day 1, with the exception of hormonal contraceptives, and in the medical opinion of the Investigator would not adversely affect the participant.
- Willingness to refrain from any other organized body weight reduction program (exercise programs or dietary modifications) from Screening until at least 4 weeks after the last dose of study drug, with the exception of MyFitnessPal which will be used in this study.
- Any weight reduction medication within 4 weeks prior to screening until at least 4 weeks after the last dose of study drug.
- Willingness to not initiate a new structured exercise program or substantially change their habitual activity while on the study.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (such as St. John’s wort) must have been/be stopped at least 14 days prior to Day 1, with the exception of acetaminophen.
- Ability and willingness to abstain from alcohol from 48 hours prior to Screening, study dosing visits and end of study/early termination visit.
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, and energy drinks) for 48 hours immediately prior to Screening, study dosing visits and End of Study or Early Termination visit.
- Ability and willingness to abstain from all tobacco and nicotine products from 48 hours prior to Day 1 until Day 79.
- Good physical and mental health based on medical history, physical examination, clinical laboratory test results, electrocardiogram and vital signs.
- Participants should have and be able to use a Smart phone, iPad, or laptop.
Exclusion Criteria26
- Any findings in the medical examination (including blood pressure, heart rate, or electrocardiogram) deviating from normal and assessed as clinically relevant by the Investigator.
- Any immune related sensitivity, history of severe allergy or hypersensitivity or ongoing clinically important allergy or hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to RES-010.
- Any vaccination received within 30 days before Screening.
- Relevant hepatic parameters exceeding alanine transaminase or aspartate transferase greater than 1.5 times upper limit of normal, total bilirubin greater than upper normal limit (exclusion of Gilbert’s disease), alkaline phosphatase greater than 1.3 times the upper normal limit at Screening or Day minus 1.
- Thyroid stimulating hormone levels outside normal limits of the clinical laboratory’s reference range at Screening.
- Abnormal amylase levels or chronic pancreatic illness at Screening.
- Participants with clinical or biochemical (International Normalized Ratio greater than 1.2 or platelet count less than the lower limit of normal evidence of hepatic decompensation at Screening or on Day 1.
- Previous participation in the current study.
- Known allergy to local anaesthetics.
- Employee of any organization associated with this study.
- History of clinically relevant drug and/or food allergies.
- Any previous weight reduction surgery, clinically significant body weight change 90 days prior to Day 1, or current (or within the last 3 months) participation in organized body weight reduction program, with the exception of MyFitnessPal which will be used in this study.
- Use of tobacco products, vaping or nicotine products (such as patches, gum) within 30 days prior to Day 1.
- History of alcohol abuse or drug addiction (including drugs such as cannabis and cannabis products) within the past 2 years.
- Positive drug and/or alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma-hydroxybutyric acid (GHB), tricyclic antidepressants, and alcohol) at Screening and Day 1.
- History of alcohol consumption of no more than 10 standard drinks per week and no more than 4 standard drinks on any one day, within 3 months prior to Screening.
- Positive screen for hepatitis B surface antigen (HBsAg), anti–hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibodies, or Human Immunodeficiency Virus (HIV) 1 and 2 antibodies.
- Received active investigational product for any investigational study within 30 days prior to Day 1 or a weight loss investigational study within the last 6 months. Participation in 4 other investigational studies in the 12 months prior to Day 1.
- Donation or loss of more than 450 mL of blood within 60 days prior to Day 1, donation, or loss of more than 1.5 litres of blood (for male participants) or more than 1.0 litres of blood (for female participants) in the 10 months prior to Day 1 in the current study.
- Significant and/or acute illness within 5 days prior to Day 1 that may impact safety assessments, in the opinion of the Investigator.
- Poor venous access.
- A mean corrected QT interval using Fridericia’s formula interval greater than 450 milliseconds (for males) and greater than 470 milliseconds (for females) at Screening. If the mean FQT interval using Fridericia’s formula exceeds the limits above, one additional triplicate Electrocardiogram (ECG) may be performed. If this triplicate also gives an abnormal result, the participant should be excluded from the study.
- Estimated glomerular filtration rate rate by Chronic Kidney Disease Epidemiology Collaboration below 80 mL per minute at Screening.
- Participants should refrain from consumption of any food containing poppy seeds within 48 hours prior to Screening and Day 1.
- Participants should refrain from strenuous exercise (including weightlifting) within 96 hours prior to Screening and Day 1.
- Any physical, psychological, mental and/or social reason which in the opinion of the Investigator makes the participant unsuitable for the study.
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Interventions
This study aims to find out if the study drug, RES-010, is safe and tolerable, and if RES-010 can help with weight loss. This is a dose escalation study, which means the first group enrolled will receive the lowest dose and once it is considered to be safe, the next group will be enrolled and will receive the next higher dose. Dose escalation will only proceed following review of information/results from the dosing of previous participants, including the results of blood tests and other assessments. This decision will be made by the Principal Investigator and the Sponsor if there is confirmation that it is safe to continue with the next higher dose in the next group. The study can be stopped at any time based on evaluation of the side effects of the study drug. The maximum dose of RES-010 for Cohorts 2 and 3 has not yet been determined. This study will enrol up to 36 overweight or mildly obese patients randomly assigned to either RES-010 or placebo treatment groups, with participants having a 3 in 4 chance of receiving the study drug RES-010. The study will be conducted in up to three groups (called cohorts), with 12 participants in each cohort. The study treatment groups (cohorts) include: 1. Cohort 1: subcutaneous injection in abdomen (injection under the skin) with a starting dose of 45mg of RES-010 for 12 weeks, administered as a single injection, every dosing (once per week). 2. Cohort 2: subcutaneous injection in abdomen with a next higher dose of RES-010 for 12 weeks, administered as a single injection, every dosing (once per week). The planned maximum dose for this cohort is 60 mg of RES-010 for 12 weeks, administered as a single injection, every dosing (once per week). 3. Cohort 3 (Optional): subcutaneous injection in abdomen with an additional higher or lower dose of RES-010 for 12 weeks, administered as a single injection, every dosing (once per week). The planned maximum dose for this cohort is 75 mg of RES-010 for 12 weeks, administered as a single injection, every dosing (once per week). The planned multiple ascending dose (MAD) levels are 45 mg for Cohort 1, 60 mg for Cohort 2, and 75 mg for Cohort 3. The maximum dose in the study will not exceed 75 mg. Dose escalation and final confirmation of the dose for Cohorts 2 and 3 will be based on review of emerging safety and tolerability data from the previous cohort(s), together with available Pharmacokinetics (PK) and Pharmacodynamic (PD) data, where applicable. If escalation is not supported, a lower dose may be selected or escalation may be stopped, following Sponsor/Scientific Review Committee (SRC) review. The subcutaneous injection site/location on abdomen will be closely monitored after study treatment administration in addition to safety assessments (including but not limited to Vital signs measured, Electrocardiogram (ECG), safety blood tests).
Locations(1)
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ACTRN12626000615381