Recruiting

Phase 1

VK2735A Phase 1 Study of VK2735 in Obese Adults Without Comorbidities

Sponsor:

Viking Therapeutics, Inc.

Code:

NCT07838740

Conditions

Obese Adults

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

VK2735 Drug

Placebo

Study Details

Brief summary:

The goal of this Phase 1, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VK2735 in adults who are obese (BMI ≥ 30 kg/m2) without comorbidities.

Conditions

Obese Adults

Study ID

NCT07838740

Start date

Nov 18, 2025

Status verified date

Sep, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo Subcutaneously (SC) weekly

experimental: VK2735 Dose Level 2

VK2735 subcutaneously weekly followed by Placebo subcutaneously weekly

experimental: VK2735 Dose Level 3

VK2735 subcutaneously weekly followed by VK2735 subcutaneously weekly

experimental: VK2735 Dose Level 4

VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week

experimental: VK2735 Dose Level 5