Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers
Condition: Obesity; Weight Loss; Overweight and Obesity
MeSH terms: Obesity; Overweight; Weight Loss
Intervention: RZL-012; Placebo
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a consecutive 4 cohort, dose escalation placebo-controlled clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double Blind, Randomized, Placebo Controlled
Enrollment: 32.0
Sex: Male
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Overweight; Thermogenesis; Fat reduction

Summary:

      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.
    

Eligibility criteria:

        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.