Safety and Drug Concentrations of REGN20934 in Adults With Overweight or Obesity

NCT07594093 — Phase 1, Recruiting, 90 participants, Regeneron Pharmaceuticals

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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

Registry	NCT07594093
Status	Recruiting
Phase	Phase 1
Study type	Interventional; randomized, sequential, masking: quadruple, treatment
Enrollment	90 (Estimated)
Sponsor	Regeneron Pharmaceuticals (Industry)
Conditions	Overweight or Obesity
Interventions	REGN20934, Placebo (Drug)
Dates	start 2026-06-29, primary completion 2027-02-22 (estimated), completion 2027-02-22 (estimated), first posted 2026-05-18, last updated 2026-09-25
Locations	1 site in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
REGN20934	Experimental	Drug: REGN20934
Placebo	Placebo comparator	Drug: Placebo

REGN20934 (Drug): Administered per the protocol
Placebo (Drug): Administered per the protocol

+Outcome measures

Primary outcomes

Occurrence of Treatment Emergent Adverse Events (TEAEs) [Up to 16 weeks]
Severity of TEAEs [Up to 16 weeks]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Parexel International	Glendale, California	United States	Recruiting

+Investigators

Clinical Trial Management, Study director, Regeneron Pharmaceuticals