A Phase 1 Study of VK2735 in Obese Adults Without Comorbidities

NCT07838740 | Recruiting Phase 1 FDA Drug

• 1 other identifier: VK2735-102
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

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

Keywords

Weight loss

Outcome Measures

Primary Outcomes (1)

• Evaluate the Safety and Tolerability VK2735

  -Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)

  33 weeks

Secondary Outcomes (1)

• Evaluate the Pharmacokinetic profile of VK23735

  38 weeks

Study Arms (18)

Placebo

PLACEBO COMPARATOR

Placebo Subcutaneously (SC) weekly

Drug: Placebo

VK2735 Dose Level 2

EXPERIMENTAL

VK2735 subcutaneously weekly followed by Placebo subcutaneously weekly

Drug: VK2735 Drug; Drug: Placebo

VK2735 Dose Level 3

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 subcutaneously weekly

Drug: VK2735 Drug

VK2735 Dose Level 4

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week

Drug: VK2735 Drug

VK2735 Dose Level 5

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly

Drug: VK2735 Drug

VK2735 Dose Level 6

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly

Drug: VK2735 Drug

VK2735 Dose Level 7

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly

Drug: VK2735 Drug

VK2735 Dose Level 8

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly

Drug: VK2735 Drug

VK2735 Dose Level 9

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly

Drug: VK2735 Drug

VK2735 Dose Level 10

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week

Drug: VK2735 Drug

VK2735 Dose Level 11

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week

Drug: VK2735 Drug

VK2735 Dose Level 12

EXPERIMENTAL

VK2735 subcutaneously weekly followed by Placebo subcutaneously weekly

Drug: VK2735 Drug; Drug: Placebo

VK2735 Dose Level 14

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 orally once daily

Drug: VK2735 Drug

VK2735 Dose Level 15

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 orally once daily

Drug: VK2735 Drug

VK2735 Dose Level 16

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 orally once daily

Drug: VK2735 Drug

VK2735 Dose Level 17

EXPERIMENTAL

VK2735 subcutaneously weekly followed by Placebo orally once weekly

Drug: VK2735 Drug; Drug: Placebo

VK2735 Dose Level 18

EXPERIMENTAL

VK2735 subcutaneously weekly followed by Placebo orally once daily

Drug: VK2735 Drug; Drug: Placebo

VK2735 Dose Level 13

EXPERIMENTAL

VK2735 subcutaneously weekly followed by VK2735 orally weekly

Drug: VK2735 Drug

Interventions

VK2735 Drug DRUG

SC or oral once daily, once weekly, every other week, or monthly

VK2735 Dose Level 10; VK2735 Dose Level 11; VK2735 Dose Level 12; VK2735 Dose Level 13; VK2735 Dose Level 14; VK2735 Dose Level 15; VK2735 Dose Level 16; VK2735 Dose Level 17; VK2735 Dose Level 18; VK2735 Dose Level 2; VK2735 Dose Level 3; VK2735 Dose Level 4; VK2735 Dose Level 5; VK2735 Dose Level 6; VK2735 Dose Level 7; VK2735 Dose Level 8; VK2735 Dose Level 9

Placebo DRUG

SC or oral once daily or once weekly

Placebo; VK2735 Dose Level 12; VK2735 Dose Level 17; VK2735 Dose Level 18; VK2735 Dose Level 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viking Therapeutics, Inc.: lead

Study Sites (2)

Viking Clinical Site #001

Lake Forest, California, 92630, United States

RECRUITING

Viking Clinical Site #002

Miami, Florida, 33147, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hubert C Chen, MD

CONTACT

8587044660; clinicaltrials@vikingtherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 24, 2026
• Study Start: November 18, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)