VK2735

Drug information

Delivery device(s)

Commercial presentations planned as autoinjector and vial/syringe (CordenPharma agreement, March 2025). Device used in clinical trials not disclosed.

Scale-up prospects

Multi-year CordenPharma agreement (March 2025): multiple metric tons of API per year and an annual commitment of 100 million autoinjectors plus 100 million vial and syringe products for the SC formulation on dedicated lines; USD 150 million prepayments over 2025 to 2028; expandable at Viking's option.

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

VANQUISH 1

Identifier

NCT07104500

Link

https://clinicaltrials.gov/study/NCT07104500

Phase

Phase III

Status

Active, not recruiting

Sponsor

Viking Therapeutics, Inc.

More details

This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) with one or more weight related comorbid condition without Type 2 Diabetes.

Purpose

VK2735 for Weight Management Phase 3

Interventions

Intervention 1

Intervention 2

Intervention 3

Intervention 4

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-06-23

Anticipated Date of Last Follow-up
2025-11-20

Estimated Primary Completion Date
2027-07-01

Estimated Completion Date
2027-08-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. Age ≥18 years of age at the time of signing the informed consent 2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co- morbid condition (treated or untreated) * Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease * Cardiovascular disease includes, for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure * BMI calculated at the Screening visit will be used to determine eligibility Exclusion Criteria: 1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation 2. Self-reported body weight change of 5% or more within

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

4500

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Triple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

VK2735-101

Identifier

NCT05203237

Link

https://clinicaltrials.gov/study/NCT05203237

Phase

Phase I

Status

Completed

Sponsor

Viking Therapeutics, Inc.

More details

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).

Purpose

Phase 1 Study to Evaluate the Safety and Tolerability of VK2735

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2021-12-14

Anticipated Date of Last Follow-up
2025-02-13

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2024-11-04

Actual Completion Date
2024-12-03

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: 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 Exclusion Criteria: Participants with any level of disease or organ system dysfunction as identified during physical examination, medical history or laboratory testing, as asses

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

92

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

VENTURE (VK2735-201)

Identifier

NCT06068946

Link

https://clinicaltrials.gov/study/NCT06068946

Phase

Phase II

Status

Completed

Sponsor

Viking Therapeutics, Inc.

More details

13-week treatment with titration to final dose. Mean weight reduction 9.1% (2.5 mg) to 14.7% (15 mg) vs 1.7% placebo; 93% of VK2735-treated participants achieved ≥5% weight loss vs 12% placebo. Primary and all secondary endpoints met. Published in Obesity (Bays et al., 2026). This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. VK2735 or matched placebo will be administered once weekly.

Purpose

VK2735 for Weight Management Phase 2

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2023-08-31

Anticipated Date of Last Follow-up
2025-02-10

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2024-02-27

Actual Completion Date
2024-04-02

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. Age ≥18 years of age at the time of signing the informed consent 2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI \<50 kg/m2 Exclusion Criteria: 1. History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation 2. Self-reported body weight change of 5% or more within 3 months of screening 3. Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational) 4. Current or past diagnosis of chronic pancreatitis 5. Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened) 6. Any GLP-1 recep

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

176

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Triple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

VK2735-102 (maintenance dosing study)

Identifier

NCT07838740

Link

https://clinicaltrials.gov/study/NCT07838740

Phase

Phase I

Status

Recruiting

Sponsor

Viking Therapeutics, Inc.

More details

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.

Purpose

A Phase 1 Study of VK2735 in Obese Adults Without Comorbidities

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-11-18

Anticipated Date of Last Follow-up
2026-09-22

Estimated Primary Completion Date
2027-05-01

Estimated Completion Date
2027-07-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * 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. 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 oth

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

270

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

VANQUISH 2 (VK2735-302)

Identifier

NCT07104383

Link

https://clinicaltrials.gov/study/NCT07104383

Phase

Phase III

Status

Active, not recruiting

Sponsor

Viking Therapeutics, Inc.

More details

This is a phase 3, multicenter, 78-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the weight loss efficacy as well as safety, tolerability, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults with Type 2 Diabetes who are obese or overweight

Purpose

VK2735 for Weight Management Type 2 Diabetes Phase 3 (VANQUISH 2)

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-06-23

Anticipated Date of Last Follow-up
2026-04-03

Estimated Primary Completion Date
2027-07-01

Estimated Completion Date
2027-08-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. Age ≥18 years of age at the time of signing the informed consent 2. Body mass index (BMI) ≥27 kg/m2 3. Have Type 2 Diabetes Mellitus according to the American Diabetes Association with HbA1c ≥ 7% to ≤ 11% at screening, on stable therapy for the last 3 months prior to Screening. Type 2 diabetes mellitus may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling), EXCEPT for amylin analogues or dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1R agonists or dual GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists Exclusion Criteria: 1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation 2. Self-reported body weight

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

1100

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Triple-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL

Publications

Weekly Subcutaneous VK2735, a GIP/GLP-1 Receptor Dual Agonist, for Weight Management: Phase 2, Randomized, 13-Week VENTURE Study

Harold E. Bays — Obesity — 2026-01-08

Objective

This study aimed to determine doses of VK2735, a novel glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide (GLP-1/GIP) receptor dual agonist, that are effective for weight loss over 13 weeks of treatment.

Methods

VENTURE was a phase 2, randomized, double-blind, placebo-controlled, dose-ranging study of weekly subcutaneous VK2735 in adults with obesity or overweight and ≥ 1 weight-related comorbidity. Participants with diabetes mellitus were ineligible. The primary endpoint was percent change from baseline in body weight at Week 13. Secondary efficacy endpoints were observed and change from baseline weight loss and the proportion of participants losing ≥ 5% and ≥ 10% of baseline weight.

Results

Study was conducted between August 2023 and February 2024. Mean weight reduction with active treatment ranged from 9.2 kg (2.5 mg dose) to 14.6 kg (15 mg dose), corresponding to 9.1% and 14.7% weight reductions, respectively; the placebo group had a 1.8 kg (1.7%) reduction. In the active treatment groups, 93% (130/140) of participants had a ≥ 5% weight reduction, compared with 12% (4/34) of participants with placebo treatment. The common adverse events (AEs) were gastrointestinal, which decreased in reported frequency after dose titration to steady state.

Conclusions

All subcutaneous doses of VK2735 significantly reduced body weight. The AE profile of VK2735 was primarily gastrointestinal, with decreased reported frequency upon continued use.

Trial Registration

ClinicalTrials.gov identifier NCT06068946

Additional documents

No documents were uploaded

Useful links

• Topline Results from Maintenance Study of GLP-1/GIP Agonist VK2735 — Viking Therapeutics Website, 2026-09-22