Efficacy And Safety of Olatorepatide in Adults With Overweight or Obesity Without Diabetes

Browse trials for

• Overweight 3,767
• Body Weight 1,237

Keywords

• Body weight
• Waist circumference
• Glucagon-Like Peptide-1 (GLP-1)
• Glucagon-Like Peptide-1 Receptor Agonist (GLP-1-RA)
• Control appetite
• Control blood sugar
• Gastric Inhibitory Polypeptide (GIP)

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 73 across 3,263 interventional studies indexed under Overweight.

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 410 studies on the registry; 93 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 79 (64%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Olatorepatide-Dose 1

  Drug: Olatorepatide

• Experimental
  Olatorepatide-Dose 2

  Drug: Olatorepatide

• Experimental
  Olatorepatide-Dose 3

  Drug: Olatorepatide

• Placebo comparator
  Placebo-Dose 1

  Drug: Placebo

• Placebo comparator
  Placebo-Dose 2

  Drug: Placebo

Interventions

• DrugOlatorepatide

  Administered per the protocol

  Also known as: HS-20094

• DrugPlacebo

  Administered per the protocol

Primary outcomes

1. Percent change in body weight

   Time frame: From baseline to week 72

Secondary outcomes

1. Change in body weight

   Time frame: From baseline to week 72

2. Occurrence of ≥5% reduction in body weight

   Time frame: From baseline to week 72

3. Occurrence of ≥10% reduction in body weight

   Time frame: From baseline to week 72

4. Occurrence of ≥15% reduction in body weight

   Time frame: From baseline to week 72

5. Occurrence of ≥20% reduction in body weight

   Time frame: From baseline to week 72

6. Change in waist circumference

   Time frame: From baseline to week 72

7. Change in Systolic Blood Pressure (SBP)

   Time frame: From baseline to week 72

8. Change in Diastolic Blood Pressure (DBP)

   Time frame: From baseline to week 72

9. Change in Hemoglobin A1C (HbA1c)

   Time frame: From baseline to week 72

10. Change in Fasting Plasma Glucose (FPG)

    Time frame: From baseline to week 72

11. Percent change in total cholesterol

    Time frame: From baseline to week 72

12. Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: From baseline to week 72

13. Percent change in High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: From baseline to week 72

14. Percent change in non-HDL-C

    Time frame: From baseline to week 72

15. Percent change in Very-Low-Density Lipoprotein Cholesterol (VLDL-C)

    Time frame: From baseline to week 72

16. Percent change in triglycerides

    Time frame: From baseline to week 72

17. Percent change in Apolipoprotein B (ApoB)

    Time frame: From baseline to week 72

18. Percent change in high-sensitivity C-Reactive Protein (hs-CRP)

    Time frame: From baseline to week 72

19. Percent change in urine Albumin-Creatinine Ratio (uACR)

    Time frame: From baseline to week 72

20. Change in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-Lite-CT) Physical Function score

    The IWQOL-Lite-CT is a 20-item PRO measure designed to assess the impact of changes in weight on patients' physical and psychosocial functioning. The range of possible scores for the IWQOL-Lite-CT is 0 to 100. Higher values indicate better participant functioning.

    Time frame: From baseline to week 72

21. Change in IWQOL-Lite-CT Physical Composite score

    The IWQOL-Lite-CT is a 20-item PRO measure designed to assess the impact of changes in weight on patients' physical and psychosocial functioning. The range of possible scores for the IWQOL-Lite-CT is 0 to 100. Higher values indicate better participant functioning.

    Time frame: From baseline to week 72

22. Change in IWQOL-Lite-CT Total score

    The IWQOL-Lite-CT is a 20-item PRO measure designed to assess the impact of changes in weight on patients' physical and psychosocial functioning. The range of possible scores for the IWQOL-Lite-CT is 0 to 100. Higher values indicate better participant functioning.

    Time frame: From baseline to week 72

23. Concentrations of olatorepatide in plasma

    Time frame: Up to approximately 76 weeks

24. Occurrence of Anti-Drug Antibody (ADA) to olatorepatide

    Time frame: Up to approximately 72 weeks

25. Magnitude of ADA to olatorepatide

    Time frame: Up to approximately 72 weeks

26. Occurrence of Neutralizing Antibody (NAb) to olatorepatide

    Time frame: Up to approximately 72 weeks

27. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 76 weeks

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy

Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Data sharing details ↗ · vivli.org