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

NCT07594093 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: R20934-OB-2561
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Conditions

Overweight or Obesity

Keywords

Overweight; Obesity or without diabetes

Outcome Measures

Primary Outcomes (2)

• Occurrence of Treatment Emergent Adverse Events (TEAEs)

  Up to 16 weeks

• Severity of TEAEs

  Up to 16 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

REGN20934

EXPERIMENTAL

Drug: REGN20934

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

REGN20934 DRUG

Administered per the protocol

REGN20934

Placebo DRUG

Administered per the protocol

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Has a Body Mass Index (BMI) 25 to 35 kg/m\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor unblinded
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): February 22, 2027
• Study Completion (Estimated): February 22, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf