Safety and Drug Concentrations of REGN20934 in Adults With Overweight or Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: REGN20934, Placebo.
- Who it may be relevant to
- Registry conditions: Overweight or Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of REGN20934 in Adult Participants With Overweight or Obesity
Overview
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
- Drug REGN20934
Administered per the protocol - Drug Placebo
Administered per the protocol
Primary outcome measures
- Occurrence of Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 16 weeks]
- Severity of TEAEs [Time frame: Up to 16 weeks]
Secondary outcome measures (3)
- REGN20934 concentration in serum [Time frame: Up to 16 weeks]
- Occurrence of Anti-Drug Antibodies (ADAs) to REGN20934 [Time frame: Up to 16 weeks]
- Magnitude of ADAs to REGN20934 [Time frame: Up to 16 weeks]
Eligibility criteria
Inclusion criteria
- Has a Body Mass Index (BMI) 25 to 35 kg/m\^2
- Females must be of non-childbearing potential
Exclusion criteria
- 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
Note: Other protocol defined inclusion/exclusion criteria apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- California Clinical Trials Medical Group — Glendale
Identifiers
NCT: NCT07594093 · R20934-OB-2561