Safety and Drug Concentrations of REGN20934 in Adults With Overweight or Obesity
ConditionOverweight or Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRegeneron Pharmaceuticals
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Has a Body Mass Index (BMI) 25 to 35 kg/m²
Females must be of non-childbearing potential
Disqualifiers
A self-reported change of body weight >5 kg within approximately 90 days of visit 2
History of type 1 or type 2 diabetes
History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as defined in the protocol
Trial design
Design model
Sequential
Treatments tested in this trial
REGN20934
DrugAdministered per the protocol
Placebo
DrugAdministered per the protocol
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: REGN20934Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame
Up to 16 weeks2
Severity of TEAEs
Time frame
Up to 16 weeksSecondary outcomes
1
REGN20934 concentration in serum
Time frame
Up to 16 weeks2
Occurrence of Anti-Drug Antibodies (ADAs) to REGN20934
Time frame
Up to 16 weeks3
Magnitude of ADAs to REGN20934
Time frame
Up to 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov