Obese AdultsPhase 1NCT07846033
A Phase 1 Study of VK3019 in Overweight and Obese Adults Without Comorbidities
A Phase 1 study testing SC VK3019 in people with Obese Adults, run by Viking Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of VK3019 in overweight and obese adults 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?
- SC VK3019
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2026to Nov 2026
- 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 signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- Participants 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 Investigator.
- Body mass index ≥ 27 kg/m2 and < 40 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.
- History or presence of clinically significant acute or unstable cerebrovascular (stroke), hepatic, renal, gastrointestinal, pulmonary, immunological, endocrine, diabetes, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant.
- Current or prior diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes).
- History of, or current, clinically significant liver disease, gallbladder disease (with the exception of Gilbert's Syndrome), as assessed by the Investigator.
- History of drug or alcohol abuse (ie, >14 drinks/week for women or 21 drinks/week for men [1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor]) within 12 months of Screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Viking Clinical Site #001
Lake Forest, California, 92630
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VK3019, an Amylin and Calcitonin Receptor Agonist, in Overweight and Obese Adults Without Comorbidities
This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of VK3019 in overweight and obese adults without comorbidities.
Read the detailed description
Approximately 56 participants will enroll into one of 7 cohorts (Cohort 1 through Cohort 7 N=8 per cohort) and will receive either VK3019 or VK3019 matching placebo (for a total of 6 VK3019 and 2 placebo per cohort).
All dose cohorts will first dose 2 sentinels (1 active and 1 placebo) to be followed by the rest of the cohort (ROC) no sooner than 48 hours following sentinel dosing. In all cohorts, the first 2 enrolled participants (sentinel pair) will be randomized in a 1:1 ratio and in a double-blind fashion, to receive either VK3019 or matching VK3019 placebo. The 2 sentinel participants will be dosed on the same day (Day 1). If deemed safe by the Investigator, a minimum 2 days after sentinel pair dosing, the same dose will be administered to the ROC participants. The rest of the participants within cohort will be randomized 5:1 where 1 is the remaining placebo.
Safety Review Committee (SRC) meetings will be held prior to dose escalation during the study in a blinded fashion. The decisions on dose escalation will be based on safety and laboratory data from each cohort.
- Conditions
- Obese Adults
- Being tested
- SC VK3019, Matching 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.
SC VK3019Drug
Single dose VK3019
Matching placeboDrug
Single dose matching placebo
| Study group | Role | What they receive |
|---|---|---|
| VK3019 Dose Level 1 | Experimental | Single-dose VK3019 or placebo administered subcutaneously Receives: Drug: SC VK3019; Drug: Matching placebo |
| VK3019 Dose Level 2 | Experimental | Single-dose VK3019 or placebo administered subcutaneously Receives: Drug: SC VK3019; Drug: Matching placebo |
| VK3019 Dose Level 3 | Experimental | Single-dose VK3019 or placebo administered subcutaneously Receives: Drug: SC VK3019; Drug: Matching placebo |
| VK3019 Dose Level 4 | Experimental | Single-dose VK3019 or placebo administered subcutaneously Receives: Drug: SC VK3019; Drug: Matching placebo |
| VK3019 Dose Level 5 | Experimental | Single-dose VK3019 or placebo administered subcutaneously Receives: Drug: SC VK3019; Drug: Matching placebo |
| VK 3019 Dose Level 6 | Experimental | Single-dose VK3019 or placebo administered subcutaneously Receives: Drug: SC VK3019; Drug: Matching placebo |
| VK3019 Dose Level 7 | Experimental | Single-dose VK3019 or placebo administered subcutaneously Receives: Drug: SC VK3019; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of single doses of subcutaneous administration of VK3019
-Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Measured: 36 days
Secondary outcomes (1)
Evaluate the Pharmacokinetic profile of single doses of subcutaneous administration of VK3019
Pharmacokinetic profile of subcutaneous VK3019 by measuring peak plasma concentration (Cmax)
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start6 Jul 2026
- Primary completion2 Oct 2026 (estimated)
- Study completionNov 2026 (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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 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
- NCT07846033
- Sponsor's protocol ID
- VK3019-101
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 29 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 29 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, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VK3019, an Amylin and Calcitonin Receptor Agonist, in Overweight and Obese Adults Without Comorbidities
- ClinicalTrials.gov ID
- NCT07846033
- Acronym / sponsor ID
- VK3019-101
- Conditions
- Obese Adults
- Keywords
- Weight loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Viking Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 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.
This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of VK3019 in overweight and obese adults without comorbidities.
Detailed description
Approximately 56 participants will enroll into one of 7 cohorts (Cohort 1 through Cohort 7 N=8 per cohort) and will receive either VK3019 or VK3019 matching placebo (for a total of 6 VK3019 and 2 placebo per cohort).
All dose cohorts will first dose 2 sentinels (1 active and 1 placebo) to be followed by the rest of the cohort (ROC) no sooner than 48 hours following sentinel dosing. In all cohorts, the first 2 enrolled participants (sentinel pair) will be randomized in a 1:1 ratio and in a double-blind fashion, to receive either VK3019 or matching VK3019 placebo. The 2 sentinel participants will be dosed on the same day (Day 1). If deemed safe by the Investigator, a minimum 2 days after sentinel pair dosing, the same dose will be administered to the ROC participants. The rest of the participants within cohort will be randomized 5:1 where 1 is the remaining placebo.
Safety Review Committee (SRC) meetings will be held prior to dose escalation during the study in a blinded fashion. The decisions on dose escalation will be based on safety and laboratory data from each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| VK3019 Dose Level 1 | Experimental | Drug: SC VK3019, Drug: Matching placeboSingle-dose VK3019 or placebo administered subcutaneously |
| VK3019 Dose Level 2 | Experimental | Drug: SC VK3019, Drug: Matching placeboSingle-dose VK3019 or placebo administered subcutaneously |
| VK3019 Dose Level 3 | Experimental | Drug: SC VK3019, Drug: Matching placeboSingle-dose VK3019 or placebo administered subcutaneously |
| VK3019 Dose Level 4 | Experimental | Drug: SC VK3019, Drug: Matching placeboSingle-dose VK3019 or placebo administered subcutaneously |
| VK3019 Dose Level 5 | Experimental | Drug: SC VK3019, Drug: Matching placeboSingle-dose VK3019 or placebo administered subcutaneously |
| VK 3019 Dose Level 6 | Experimental | Drug: SC VK3019, Drug: Matching placeboSingle-dose VK3019 or placebo administered subcutaneously |
| VK3019 Dose Level 7 | Experimental | Drug: SC VK3019, Drug: Matching placeboSingle-dose VK3019 or placebo administered subcutaneously |
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 signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- Participants 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 Investigator.
- Body mass index ≥ 27 kg/m2 and < 40 kg/m2.
- Willing to comply with contraceptive requirements.
Key exclusion criteria (6 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.
- History or presence of clinically significant acute or unstable cerebrovascular (stroke), hepatic, renal, gastrointestinal, pulmonary, immunological, endocrine, diabetes, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant.
- Current or prior diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes).
- History of, or current, clinically significant liver disease, gallbladder disease (with the exception of Gilbert's Syndrome), as assessed by the Investigator.
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 |
|---|---|---|
| SC VK3019Single dose VK3019 | Drug | VK 3019 Dose Level 6, VK3019 Dose Level 1, VK3019 Dose Level 2, VK3019 Dose Level 3, VK3019 Dose Level 4, VK3019 Dose Level 5, VK3019 Dose Level 7 |
| Matching placeboSingle dose matching placebo | Drug | VK 3019 Dose Level 6, VK3019 Dose Level 1, VK3019 Dose Level 2, VK3019 Dose Level 3, VK3019 Dose Level 4, VK3019 Dose Level 5, VK3019 Dose Level 7 |
Primary outcome
Evaluate the safety of single doses of subcutaneous administration of VK3019
Time frame: 36 days
-Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
1 secondary outcome
Evaluate the Pharmacokinetic profile of single doses of subcutaneous administration of VK3019
Time frame: 36 days
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 29 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC VK3019 in people with Obese Adults, run by Viking Therapeutics, Inc. at 1 site 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 6 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 29 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 1 site 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. 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 of single doses of subcutaneous administration of VK3019 (time frame: 36 days). 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 29 Sep 2026.