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Purpose

This study will test an experimental drug called olatorepatide ("study drug") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes. The study is looking at: - What side effects the study drug might cause - How much study drug is in the blood at different times - How well the study drug works - What effects the study drug may have on the body at different dosing schedules - If the body makes antibodies to the study drug as this may cause the study drug to not work as well

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Body Mass Index (BMI) ≥30.0 kg/m^2 to <45.0 kg/m^2 at screening OR 2. BMI ≥27.0 kg/m^2 at screening with at least 1 of the following weight-related co-morbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease as described in the protocol

Exclusion Criteria

  1. Previous or current diagnosis of Type 1 or Type 2 diabetes at screening 2. Change in body weight >5 kg within approximately 3 months before screening as described in the protocol 3. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions as described in the protocol 4. History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones 5. History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Olatorepatide arm 1
  • Drug: Olatorepatide
    Administered per the protocol
    Other names:
    • HS-20094
Experimental
Olatorepatide arm 2
  • Drug: Olatorepatide
    Administered per the protocol
    Other names:
    • HS-20094
Experimental
Olatorepatide arm 3
  • Drug: Olatorepatide
    Administered per the protocol
    Other names:
    • HS-20094
Experimental
Olatorepatide arm 4
  • Drug: Olatorepatide
    Administered per the protocol
    Other names:
    • HS-20094
Experimental
Olatorepatide arm 5
  • Drug: Olatorepatide
    Administered per the protocol
    Other names:
    • HS-20094
Active Comparator
Matching Placebo arm 6
  • Drug: Placebo
    Administered per the protocol

Recruiting Locations

Diablo Clinical Research - Flourish Research
Walnut Creek, California 94598

K2 Medical Research Maitland LLC, Main Office
Maitland, Florida 32751

Charter Research LLC - The Villages
The Villages, Florida 32162

Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida 32789

AMR Clinical - Lexington
Lexington, Kentucky 40509

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.