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

• Status: Completed
• Trial end date: 2018-12-28
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Raziel Therapeutics Ltd.
• Collaborator: Spaulding Clinical Research LLC

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.