Safety and drug levels of REGN20934 in adults with overweight or obesity
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
Run by Regeneron Pharmaceuticals · NCT07594093 · Data updated 2026-11-12
This study tests REGN20934 to see if it is safe and how it behaves in the body in adults who are overweight or have obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Glendale, California) |
| Status | Recruiting |
| Started | June 29, 2026 |
| Main results expected | February 22, 2027 |
| Study ends | February 22, 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT07594093 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with BMI 25–35 kg/m^2, non-childbearing females, and no major health conditions listed in the exclusion criteria.
✕Probably not a fit
Participants with diabetes or certain cardiovascular or other significant conditions may not benefit and are not expected to derive a therapeutic effect from this early study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase study evaluates the safety, tolerability, and pharmacokinetics of REGN20934, comparing it with placebo. Participants will have overweight or obesity and will receive REGN20934 or placebo with monitoring for side effects, drug levels in blood, and whether antibodies against REGN20934 develop. The trial aims to characterize how the body processes the drug and its potential immunogenicity. Only adults with BMI 25–35 kg/m^2 and non-childbearing females are eligible, with several exclusion criteria to minimize risk. The lead sponsor is Regeneron, with Parexel coordinating at a site in Glendale, California.
Why it matters
Potential benefit: If successful, REGN20934 could contribute to our understanding of its safety and how it behaves in people with overweight or obesity, potentially guiding future therapies.
How similar studies have gone: Earlier phases of similar monoclonal antibody studies have shown favorable safety and pharmacokinetic profiles, though this exact agent and population are being explored.
Who can join: the full rules
Show full inclusion / exclusion 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/exclusion criteria apply
Where it's running
-
Parexel International
Glendale, California, United States Recruiting
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.