Obese AdultsPhase 1NCT07838740
A Phase 1 Study of VK2735 in Obese Adults Without Comorbidities
A Phase 1 study testing VK2735 Drug in people with Obese Adults, run by Viking Therapeutics, Inc. at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obese Adults
- What is being tested?
- VK2735 Drug
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Nov 2025to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Viking Clinical Site #001
Lake Forest, California, 92630
- Recruiting
Viking Clinical Site #002
Miami, Florida, 33147
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VK2735 Administration in Adults Who Are Obese (BMI ≥ 30 kg/m2) Without Comorbidities
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.
- Conditions
- Obese Adults
- Being tested
- VK2735 Drug, Placebo
- Keywords
- Weight loss
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VK2735 DrugDrug
SC or oral once daily, once weekly, every other week, or monthly
PlaceboDrug
SC or oral once daily or once weekly
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Subcutaneously (SC) weekly Receives: Drug: Placebo |
| VK2735 Dose Level 2 | Experimental | VK2735 subcutaneously weekly followed by Placebo subcutaneously weekly Receives: Drug: VK2735 Drug; Drug: Placebo |
| VK2735 Dose Level 3 | Experimental | VK2735 subcutaneously weekly followed by VK2735 subcutaneously weekly Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 4 | Experimental | VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 5 | Experimental | VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 6 | Experimental | VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 7 | Experimental | VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 8 | Experimental | VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 9 | Experimental | VK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 10 | Experimental | VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 11 | Experimental | VK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 12 | Experimental | VK2735 subcutaneously weekly followed by Placebo subcutaneously weekly Receives: Drug: VK2735 Drug; Drug: Placebo |
| VK2735 Dose Level 14 | Experimental | VK2735 subcutaneously weekly followed by VK2735 orally once daily Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 15 | Experimental | VK2735 subcutaneously weekly followed by VK2735 orally once daily Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 16 | Experimental | VK2735 subcutaneously weekly followed by VK2735 orally once daily Receives: Drug: VK2735 Drug |
| VK2735 Dose Level 17 | Experimental | VK2735 subcutaneously weekly followed by Placebo orally once weekly Receives: Drug: VK2735 Drug; Drug: Placebo |
| VK2735 Dose Level 18 | Experimental | VK2735 subcutaneously weekly followed by Placebo orally once daily Receives: Drug: VK2735 Drug; Drug: Placebo |
| VK2735 Dose Level 13 | Experimental | VK2735 subcutaneously weekly followed by VK2735 orally weekly Receives: Drug: VK2735 Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Safety and Tolerability VK2735
-Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Measured: 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
Measured: 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start18 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viking Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838740
- Sponsor's protocol ID
- VK2735-102
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VK2735 Administration in Adults Who Are Obese (BMI ≥ 30 kg/m2) Without Comorbidities
- ClinicalTrials.gov ID
- NCT07838740
- Acronym / sponsor ID
- VK2735-102
- Conditions
- Obese Adults
- Keywords
- Weight loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Viking Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Subcutaneously (SC) weekly |
| VK2735 Dose Level 2 | Experimental | Drug: VK2735 Drug, Drug: PlaceboVK2735 subcutaneously weekly followed by Placebo subcutaneously weekly |
| VK2735 Dose Level 3 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 subcutaneously weekly |
| VK2735 Dose Level 4 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week |
| VK2735 Dose Level 5 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly |
| VK2735 Dose Level 6 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly |
| VK2735 Dose Level 7 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly |
| VK2735 Dose Level 8 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly |
| VK2735 Dose Level 9 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 subcutaneously monthly |
| VK2735 Dose Level 10 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week |
| VK2735 Dose Level 11 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 subcutaneously every other week |
| VK2735 Dose Level 12 | Experimental | Drug: VK2735 Drug, Drug: PlaceboVK2735 subcutaneously weekly followed by Placebo subcutaneously weekly |
| VK2735 Dose Level 14 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 orally once daily |
| VK2735 Dose Level 15 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 orally once daily |
| VK2735 Dose Level 16 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 orally once daily |
| VK2735 Dose Level 17 | Experimental | Drug: VK2735 Drug, Drug: PlaceboVK2735 subcutaneously weekly followed by Placebo orally once weekly |
| VK2735 Dose Level 18 | Experimental | Drug: VK2735 Drug, Drug: PlaceboVK2735 subcutaneously weekly followed by Placebo orally once daily |
| VK2735 Dose Level 13 | Experimental | Drug: VK2735 DrugVK2735 subcutaneously weekly followed by VK2735 orally weekly |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VK2735 DrugSC or oral once daily, once weekly, every other week, or monthly | Drug | 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 |
| PlaceboSC or oral once daily or once weekly | Drug | Placebo, VK2735 Dose Level 12, VK2735 Dose Level 17, VK2735 Dose Level 18, VK2735 Dose Level 2 |
Primary outcome
Evaluate the Safety and Tolerability VK2735
Time frame: 33 weeks
-Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
1 secondary outcome
Evaluate the Pharmacokinetic profile of VK23735
Time frame: 38 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VK2735 Drug in people with Obese Adults, run by Viking Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hubert C Chen, MD (8587044660, clinicaltrials@vikingtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Safety and Tolerability VK2735 (time frame: 33 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.