First in Human Study in Subjects With Obesity, But Otherwise Healthy

NCT06252220 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: DA-1726-1001
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

This is a First in Human study to evaluate the safety and tolerability of DA-1726 following single and multiple doses in participants with obesity, but otherwise healthy subjects.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  AEs, SAEs, TEAEs and AEs leading to treatment discontinuation.

  From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)

Secondary Outcomes (3)

• Pharmacokinetic

  From date of randomization (baseline) until the study discontinuation (up to 24 weeks post-dose baseline)

• Immunogenicity

  From date of randomization (baseline) until the end of the study (up to 24 weeks post-dose baseline)

• Pharmacodynamics

  From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)

Study Arms (3)

Part 1 - Single Ascending Dose

ACTIVE COMPARATOR

Single doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting.

Drug: DA-1726; Drug: Placebo to DA-1726

Part 2 - Multiple Ascending Dose

PLACEBO COMPARATOR

Multiple doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting.

Drug: DA-1726; Drug: Placebo to DA-1726

Part 3 - Titration

ACTIVE COMPARATOR

Multiple doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting, using either 1-step or 2-steps titration.

Drug: DA-1726; Drug: Placebo to DA-1726

Interventions

DA-1726 DRUG

Active

Part 1 - Single Ascending Dose; Part 2 - Multiple Ascending Dose; Part 3 - Titration

Placebo to DA-1726 DRUG

Placebo

Part 1 - Single Ascending Dose; Part 2 - Multiple Ascending Dose; Part 3 - Titration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent prior to initiation of any study specific procedures/activities.
• Males and females ≥18 to \<=65 years of age, at the time of signing informed consent, who have been diagnosed with obesity, defined by BMI.
• Except for obesity, otherwise healthy or with stable, well controlled obesity-related conditions as determined by the investigator based on a medical evaluation including physical exam, medical history, laboratory tests, and ECGs.
• Body mass index (BMI) ≥ 30.0 kg/m2 to 45.0 kg/m2 (Obesity to be confirmed by Caliper test showing body fat percentage with the average or above the average level).
• Has maintained a stable body weight during the 3 months prior to Screening (\<5% body weight change).
• Willing to maintain current diet and physical activity regimen.
• SAD Cohorts (Be willing to eat a standard diet while in the Clinical Research Unit).
• MAD Cohorts (Be willing to eat a standard diet while in the Clinical Research Unit). If appetite decreases, participants may not maintain their current diet.
• Females must be of non-reproductive potential:
• Postmenopausal defined as:
• Age of ≥55 years with no menses for at least 12 months; OR
• Age \<55 years with no menses for at least 12 months AND with a follicle-stimulating hormone level \>40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR
• History of hysterectomy; OR
• History of bilateral oophorectomy
• History of tubal ligation (surgically sterile)

You may not qualify if:

• History or clinical evidence of diabetes mellitus, including a fasting glucose of ≥ 120 mg/dL and/or HbA1c ≥ 6.5% at Screening.
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
• History of cholecystectomy \<= 6 months prior to screening.
• Subjects with screening calcitonin level of ≥15 pg/mL (calcitonin levels will be monitored during the study).
• Triglycerides ≥500 mg/dL at Screening.
• History of pancreatitis.
• Have a medical history or current evidence of clinically significant cardiac condition as evidenced by any of the following at Screening :
• QTc at Screening from locally generated data of \>450 msec in males or \>470 msec in females or history of long QT syndrome
• Supine systolic BP higher than 150 mmHg and a supine diastolic BP higher than 95 mmHg at Screening or check-in
• Supine HR of \<50 or \>100 beats per minute on 2 of 3 triplicate ECGs at Screening or check-in
• Heart block of the 1st, 2nd, or 3rd degree
• Sick sinus syndrome (irregular heartbeat patterns)
• Disorders in cardiac conduction
• Peripheral blood circulation issues
• Heart valve conditions

Sponsors & Collaborators

• NeuroBo Pharmaceuticals Inc.: lead

Study Sites (1)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33172, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Homolka, MS

  MetaVia

  STUDY DIRECTOR

Central Study Contacts

Robert Homolka, MS

CONTACT

8572991038; CRinfo@MetaViaTx.com

Ji Eun Lee, PharmD

CONTACT

8572991038; CRInfo@MetaViaTx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking is to be done at the pharmacy level. The pharmacists that do not have other responsibilities in the study will prepare and administer the drug.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 9, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): November 9, 2026
• Study Completion (Estimated): November 9, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)