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RecruitingNCT07838740Updated Sep 24, 2026

A Phase 1 Study of VK2735 in Obese Adults Without Comorbidities

A Phase 1 interventional study of VK2735 Drug and Placebo in Obese Adults, sponsored by Viking Therapeutics, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Viking Therapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Nov 2025, registered Sep 2026).
  • Started Nov 2025; still recruiting 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

Approximately 270 participants will be enrolled across two study parts: Part A and Part B. A total of 18 treatment groups are planned. Part A contains Groups 1 to 12, and Part B contains Groups 13 to 18. Part A will be completed prior to the enrollment of Part B.

Participants in Part A will be randomized equally across 12 treatment arms to receive one of 11 VK2735 dose regimens or a matching placebo regimen. Participants in Part B will be randomized equally across 6 treatment arms to receive one of four VK2735 dose regimens or matching placebo regimen. Each study part is comprised of treatment periods 1 and 2, lasting 21 weeks and 12 weeks, respectively. Study participants may receive a different dosing frequency and/or route of administration between the two periods.

02

Conditions studied

  • Obese Adults

Browse trials for

Keywords

  • Weight loss
03

In context

Weight Loss

1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.

This study's planned enrollment of 270 is above the median of 80 across 1,561 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Viking Therapeutics, Inc. is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 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).
  • (ALT) level or aspartate transaminase (AST) level > 3.0 times the for the reference range.
  • Impaired renal function with estimated (eGFR) \< 60 mL/min/1.73 m2 as measured at Screening.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
270 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo Subcutaneously (SC) weekly

    Drug: Placebo

  • Experimental
    VK2735 Dose Level 2

    VK2735 subcutaneously weekly followed by Placebo subcutaneously weekly

    Drug: VK2735 Drug · Drug: Placebo

  • Experimental
    VK2735 Dose Level 3

    VK2735 subcutaneously weekly followed by VK2735 subcutaneously weekly

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 4

    VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 5

    VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 6

    VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 7

    VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 8

    VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 9

    VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 10

    VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 11

    VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 12

    VK2735 subcutaneously weekly followed by Placebo subcutaneously weekly

    Drug: VK2735 Drug · Drug: Placebo

  • Experimental
    VK2735 Dose Level 14

    VK2735 subcutaneously weekly followed by VK2735 orally once daily

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 15

    VK2735 subcutaneously weekly followed by VK2735 orally once daily

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 16

    VK2735 subcutaneously weekly followed by VK2735 orally once daily

    Drug: VK2735 Drug

  • Experimental
    VK2735 Dose Level 17

    VK2735 subcutaneously weekly followed by Placebo orally once weekly

    Drug: VK2735 Drug · Drug: Placebo

  • Experimental
    VK2735 Dose Level 18

    VK2735 subcutaneously weekly followed by Placebo orally once daily

    Drug: VK2735 Drug · Drug: Placebo

  • Experimental
    VK2735 Dose Level 13

    VK2735 subcutaneously weekly followed by VK2735 orally weekly

    Drug: VK2735 Drug

Interventions

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

  • DrugPlacebo

    SC or oral once daily or once weekly

06

What researchers measure

Primary outcomes

  1. Evaluate the Safety and Tolerability VK2735

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

    Time frame: 33 weeks

Secondary outcomes

  1. Evaluate the Pharmacokinetic profile of VK23735

    Pharmacokinetic profile of SC VK2735 by measuring peak plasma concentration (Cmax) after weekly, every other week, or monthly administration; Pharmacokinetic profile of oral VK2735 by measuring peak plasma concentration (Cmax) after daily or weekly administration

    Time frame: 38 weeks

07

Study locations

2 of 2 sites recruiting
  • Viking Clinical Site #001
    Lake Forest, California 92630, United States
    Recruiting
  • Viking Clinical Site #002
    Miami, Florida 33147, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07838740
Responsible party
Sponsor
First posted
Sep 24, 2026
Start date
Nov 18, 2025
Primary completion
May 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Hubert C Chen, MD
Contact
clinicaltrials@vikingtherapeutics.com
8587044660

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: VK2735

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