Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-25

Study Completion Date

2018-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Obesity is a direct result of food-intake in excess of body energy expenditure. Thus, induction of increased energy expenditure via the activation of thermogenesis at targeted anatomical sites can counterbalance obesity. This trial aims to study RZL-012, a novel compound, in treating obesity by activating thermogenesis in subcutaneous fat.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of RZL-012 on Submental Fat Reduction

NCT04867434

Submental Fat

COMPLETED PHASE2

Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks

NCT05445557

Flank Mass

COMPLETED PHASE2

A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers.

NCT04086823

Submental Fat

COMPLETED PHASE2

Evaluation the Effects of Various Treatments on RZL-012-Induced Adverse Events

NCT05476679

Submental Fat

COMPLETED PHASE1/PHASE2

An Open-label Study That Will Test a Second Treatment Session of RZL-012.

NCT05763160

Submental Fat

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Obesity is a direct result of food-intake in excess of body energy expenditure. Therefore, a feasible approach to combat obesity is via energy-consuming activities, such as physical exercise. Unfortunately, our modern society is moving in the other direction, spending more time in immobilized positions, at work and at home. An alternative strategy for the induction of increased energy expenditure is via the activation of thermogenic cells that utilize fat to produce heat.RZL-012 is a novel molecule that enables de-novo generation of thermogenic tissue at favorable anatomical sites. As a result, the extra fat accumulated in obese persons will be turned into heat. This is a double blind, randomized, placebo controlled, dose escalation Phase 2a clinical trial for the evaluation of safety, efficacy and thermogenesis-induction of RZL-012 in overweight and obese volunteers. This trial aims to study the ability of RZL-012 in treating obesity via the induction of thermogenic foci in subcutaneous fat.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Weight Loss Overweight and Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

This is a consecutive 4 cohort, dose escalation placebo-controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double Blind, Randomized, Placebo Controlled

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RZL-012

A single-time injection, multiple subcutaneous injections of RZL-012 administered into 8-36 sites (0.1mL per site):

1. 40mg RZL-012 -administered at 8 sites
2. 80mg RZL-012 - administered at 16 sites
3. 120mg RZL-012 - administered at 24 sites
4. 180mg RZL-012 - administered at 36 sited

Group Type EXPERIMENTAL

RZL-012

Intervention Type DRUG

Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.

Placebo

A single-time injection, multiple subcutaneous injections of Placebo administered into 8-36 sites (0.1mL per site)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RZL-012

Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.

Intervention Type DRUG

Placebo

Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adult male subjects, 20-60 years old.
2. Subject is considered overweight and obese, with 27.5 \< BMI ≤ 34.9.
3. Significant subcutaneous abdominal fat as defined by Waist to hip ratio (WHR) ≥ 0.9.
4. Subjects with stable weight in the last 3 months by medical history.
5. Not one of the following eating disorders by subject's declaration: anorexia nervosa, bulimia nervosa.
6. Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG) and laboratory evaluation with a special emphasis on metabolic parameters (fasting glucose concentration \< 100 mg, normal blood pressure).
7. Subject is willing to refrain from sexual activity or agrees to use a double-barrier contraceptive device (e.g., condom and spermicide) for 4 weeks after treatment with RZL 012.
8. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
9. Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.

Exclusion Criteria

1. Subjects weighing less than 75 kg.
2. Subjects who have reduced/gained weight more than 5% of their current body weight in the last 3 months.
3. Unable to tolerate subcutaneous injection.
4. Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator put the subject at significant risk, are not eligible.
5. Subjects who test positive to either Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) are not eligible.
6. Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids are ineligible.
7. As a result of medical review, physical examination, the PI (or medically qualified nominee) considers the subject unfit for the study.
8. Medication use on regular basis.
9. Positive drug and alcohol tests.
10. Known sensitivity to components of the injection formulation.
11. Prior wound, tattoo or infection in the treated area.
12. Excessive growth of hair in the abdomen region.
13. Claustrophobia or MRI incompatible device or implant.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes