Weight LossPhase 1NCT05203237
Phase 1 Study to Evaluate the Safety and Tolerability of VK2735
A Phase 1 study testing VK2735 and VK2735 Drug in people with Weight Loss and NASH, run by Viking Therapeutics, Inc. at 1 site in Australia.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VK2735 in healthy adults and otherwise healthy adults who have an increased body mass index (BMI). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, NASH
- What is being tested?
- VK2735 and 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
- 92 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Dec 2021to 3 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be capable of giving signed informed consent
- 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
- Participant body weight must have been stable (no change greater than 5%) for a minimum 8 weeks prior to Screening
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
- Willing to comply with contraception 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 PI
- Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
- Participants may be excluded from the study if they have conditions 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, diabetes, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant
- Use of any investigational drug or product, or participation in an investigational drug study within 30 days prior to dosing or 5 half-lives of the drug (whichever is longest)
- Active smoker and/or user of nicotine-containing products unless the participant agrees to discontinue smoking/use of nicotine-containing products from 2 weeks before first IP dose administration through to study completion, including the Follow-up period
- Have serum triglycerides > 5.65 mmol/L (500 mg/dL) at Screening
- Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VK2735, a Dual Glucagon-like Peptide-1 and Gastric Inhibitory Polypeptide Receptor Agonist, in Healthy Adults and Otherwise Healthy Adults Who Have an Increased Body Mass Index
This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VK2735 in healthy adults and otherwise healthy adults who have an increased body mass index (BMI).
Read the detailed description
This study comprises 3 parts:
Part A (Single Ascending Dose [SAD]) will be conducted to assess the safety, tolerability, and PK profile in healthy participants following 1 single SC injection of VK2735 or VK2735 matching placebo (SAD Cohort 1 through SAD Cohort 6).
Part B (Multiple Ascending Dose [MAD]) will be conducted to assess the safety, tolerability, PK and PD profile in otherwise healthy participants who have an increased BMI following single SC injections of VK2735 or matched placebo administered once weekly for 4 consecutive weeks (MAD Cohort 1 through MAD Cohort 5).
Part C (Multiple Ascending Dose [MAD], PO) will be conducted to assess the safety, tolerability, PK and PD profiles in otherwise healthy, but obese, participants who have a BMI ≥30 kg/m2 following daily oral administration of VK2735 or matched placebo administered for 28 consecutive days (MAD-PO Cohort 1 through MAD-PO Cohort 4, with optional additional cohorts)
Safety Review Committee (SRC) meetings will be held prior to dose escalation for Part A (SAD), Part B (MAD), and Part C (MAD-PO) cohorts in the study. The decisions on dose escalation will be based on safety and laboratory data from each cohort.
- Conditions
- Weight Loss, NASH
- Being tested
- VK2735, Placebo, VK2735 Placebo, VK2735 Drug
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VK2735Biological
Administered SC
PlaceboBiological
Administered SC
VK2735 PlaceboDrug
Administered orally
VK2735 DrugDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Part A) | Placebo comparator | Placebo administered SC once in healthy participants Receives: Biological: Placebo |
| VK2735 (Part A) | Experimental | Escalating doses of VK2735 administered subcutaneously (SC) once in healthy participants. Receives: Biological: VK2735 |
| Placebo (Part B) | Placebo comparator | Placebo administered SC once weekly for four weeks in healthy participants Receives: Biological: Placebo |
| VK2735 (Part B) | Experimental | Escalating doses of VK2735 administered subcutaneously (SC) once weekly in healthy participants. Receives: Biological: VK2735 |
| VK2735 (Part C ) | Placebo comparator | Placebo administered orally daily for 28 days in healthy participants Receives: Drug: VK2735 Placebo |
| VK2735 (Part C) | Experimental | Escalating doses of VK2735 administered daily (PO) in healthy participants. Receives: Drug: VK2735 Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs)
To evaluate the safety and tolerability of single doses of subcutaneous injections of VK2735 in healthy participants
Measured: 8 days
Secondary outcomes (1)
Evaluate the Pharmacokinetic profile of VK2735
Pharmacokinetic profile of VK2735 by measuring peak plasma concentration (Cmax)
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start14 Dec 2021
- Primary completion4 Nov 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viking Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Mancini, Study director, Viking Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203237
- Sponsor's protocol ID
- VK2735-101
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2022
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VK2735, a Dual Glucagon-like Peptide-1 and Gastric Inhibitory Polypeptide Receptor Agonist, in Healthy Adults and Otherwise Healthy Adults Who Have an Increased Body Mass Index
- ClinicalTrials.gov ID
- NCT05203237
- Acronym / sponsor ID
- VK2735-101
- Conditions
- Weight Loss, NASH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Viking Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 24 Jan 2022 (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 and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VK2735 in healthy adults and otherwise healthy adults who have an increased body mass index (BMI).
Detailed description
This study comprises 3 parts:
Part A (Single Ascending Dose [SAD]) will be conducted to assess the safety, tolerability, and PK profile in healthy participants following 1 single SC injection of VK2735 or VK2735 matching placebo (SAD Cohort 1 through SAD Cohort 6).
Part B (Multiple Ascending Dose [MAD]) will be conducted to assess the safety, tolerability, PK and PD profile in otherwise healthy participants who have an increased BMI following single SC injections of VK2735 or matched placebo administered once weekly for 4 consecutive weeks (MAD Cohort 1 through MAD Cohort 5).
Part C (Multiple Ascending Dose [MAD], PO) will be conducted to assess the safety, tolerability, PK and PD profiles in otherwise healthy, but obese, participants who have a BMI ≥30 kg/m2 following daily oral administration of VK2735 or matched placebo administered for 28 consecutive days (MAD-PO Cohort 1 through MAD-PO Cohort 4, with optional additional cohorts)
Safety Review Committee (SRC) meetings will be held prior to dose escalation for Part A (SAD), Part B (MAD), and Part C (MAD-PO) cohorts in the study. 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
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo (Part A) | Placebo comparator | Biological: PlaceboPlacebo administered SC once in healthy participants |
| VK2735 (Part A) | Experimental | Biological: VK2735Escalating doses of VK2735 administered subcutaneously (SC) once in healthy participants. |
| Placebo (Part B) | Placebo comparator | Biological: PlaceboPlacebo administered SC once weekly for four weeks in healthy participants |
| VK2735 (Part B) | Experimental | Biological: VK2735Escalating doses of VK2735 administered subcutaneously (SC) once weekly in healthy participants. |
| VK2735 (Part C ) | Placebo comparator | Drug: VK2735 PlaceboPlacebo administered orally daily for 28 days in healthy participants |
| VK2735 (Part C) | Experimental | Drug: VK2735 DrugEscalating doses of VK2735 administered daily (PO) in healthy participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be capable of giving signed informed consent
- 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
- Participant body weight must have been stable (no change greater than 5%) for a minimum 8 weeks prior to Screening
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
- Willing to comply with contraception 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 PI
- Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
- Participants may be excluded from the study if they have conditions 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, diabetes, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant
- Use of any investigational drug or product, or participation in an investigational drug study within 30 days prior to dosing or 5 half-lives of the drug (whichever is longest)
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 |
|---|---|---|
| VK2735Administered SC | Biological | VK2735 (Part A), VK2735 (Part B) |
| PlaceboAdministered SC | Biological | Placebo (Part A), Placebo (Part B) |
| VK2735 PlaceboAdministered orally | Drug | VK2735 (Part C ) |
| VK2735 DrugAdministered orally | Drug | VK2735 (Part C) |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs)
Time frame: 8 days
To evaluate the safety and tolerability of single doses of subcutaneous injections of VK2735 in healthy participants
1 secondary outcome
Evaluate the Pharmacokinetic profile of VK2735
Time frame: 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- 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. This study is not recruiting at the moment.
Marianne Mancini study director
Viking Therapeutics, Inc.
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 VK2735 and VK2735 Drug in people with Weight Loss and NASH, run by Viking Therapeutics, Inc. at 1 site in Australia.
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 5 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: finished, as of the sponsor's last update on 17 Feb 2025. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious AEs (TESAEs) (time frame: 8 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 17 Feb 2025.