VK2735 in Obese Adults: A First-in-Humans Dose Rocusing Safety and PK/PD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 trial in adults with obesity but no comorbidities. It will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of VK2735 across multiple dose regimens. The study has two parts with several dose groups and a total of about 270 participants, each part lasting several weeks with different dosing periods. Participants may switch dosing frequency or route between the two periods while remaining blinded to treatment. The trial is conducted at two Viking Therapeutics sites in California and Florida.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must be capable of giving a signed informed consent form (ICF).
* Must be medically healthy, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of IP in the opinion of the study Investigator.
* BMI ≥ 30 kg/m2.
* Willing to comply with contraceptive requirements.

Exclusion Criteria:

* Participants with any level of disease or organ system dysfunction as identified during physical examination, medical history, or laboratory testing, as assessed by the Investigator.
* Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion or drug absorption.
* Any condition that might compromise safety or other endpoints in the study as judged by the Sponsor (or designee) or Investigator.
* History or presence of clinically significant acute or unstable cerebrovascular (stroke), hepatic, renal, gastrointestinal, pulmonary, immunological, endocrine, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant.
* Current or past diagnosis of diabetes mellitus (including type 1 and type 2, except gestational diabetes).
* Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia syndrome type 2 (MEN-2).
* Alanine aminotransferase (ALT) level or aspartate transaminase (AST) level \> 3.0 times the ULN for the reference range.
* Impaired renal function with estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 as measured at Screening.

Where it's running

• Viking Clinical Site #001
  Lake Forest, California, United States Recruiting
• Viking Clinical Site #002
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Hubert C Chen, MD
• Email: clinicaltrials@vikingtherapeutics.com
• Phone: 8587044660

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.