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

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• DA-1726 — DRUG
  Active
• Placebo to DA-1726 — DRUG
  Placebo

Study Details

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.

Key Dates

Start date

Mar 25, 2024

Status verified

Apr 2026

Primary completion

Nov 9, 2026

Completion

Nov 9, 2026

Study Design

Enrollment

139 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Part 1 - Single Ascending Dose
  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.
• Placebo Comparator: Part 2 - Multiple Ascending Dose
  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.
• Active Comparator: Part 3 - Titration
  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.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline) ]

Central Contacts

• Robert Homolka, MS
  8572991038
  [email protected]
• Ji Eun Lee, PharmD
  8572991038
  [email protected]

Locations (1)

Find similar trials in Miami, FL

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