Overweight or Obesity
Conditions
Keywords
Overweight, Obesity or without diabetes
Brief summary
This study will test a study drug called REGN20934 to see how safe and well tolerated this drug is, as well as how the drug is processed in the body for participants with overweight or obesity. The study is looking at: * What side effects REGN20934 might cause * How much REGN20934 is in the blood at different times * If the body makes antibodies to REGN20934
Interventions
DRUGREGN20934
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor unblinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Has a Body Mass Index (BMI) 25 to 35 kg/m\^2 2. Females must be of non-childbearing potential Key
Exclusion criteria
1. A self-reported change of body weight \>5 kg within approximately 90 days of visit 2 2. History of type 1 or type 2 diabetes 3. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as defined in the protocol Note: Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAEs) | Up to 16 weeks |
| Severity of TEAEs | Up to 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| REGN20934 concentration in serum | Up to 16 weeks |
| Occurrence of Anti-Drug Antibodies (ADAs) to REGN20934 | Up to 16 weeks |
| Magnitude of ADAs to REGN20934 | Up to 16 weeks |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed