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Completed

NCT Number: NCT06309667

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.

This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.

This study will be conducted in 3 Parts (Part A, B and C), with up to 5 cohorts in each part.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Catholic University Seoul St.Mary Hospital,

Seocho, Seoul, 06591, South Korea

About this study

Part A (SAD):

In Part A, subjects will receive a single dose of study drug, and the safety and efficacy of PG-102(MG12) will be evaluated in healthy subjects.

Part B (MAD):

In Part B, subjects will receive once-weekly doses of the study drug for 4 weeks, and the safety and efficacy of PG-102(MG12) will be evaluated in otherwise healthy overweight adult subjects.

Part C (MAD):

In Part C, obese participants will receive five repeated subcutaneous doses of the study drug, and the safety and tolerability of PG-102 (MG12) will be assessed across two cohorts based on prior safety data from Part B.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent
  • Body mass index (BMI) of 18 to 30kg/m2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B and Body mass index (BMI) 30 kg/m² or higher for Part C

[Exclusion Criteria]

  • History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and/or other foods within 90 days prior to screening:
  • Drugs that affect body weight (such as obesity medications, psychiatric drugs, beta blockers, diuretics, contraceptives, female hormones, proton-pump inhibitors (PPIs), H2 receptor antagonists, health functional foods/supplements, and formulas designed for weight control).
  • Drugs that have the potential to impact blood sugar, liver fat, and intestinal microorganisms (including GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones (TZDs), fish oil, polyunsaturated fatty acids (PUFA), and ursodeoxycholic acid (UDCA)), as well as individuals who are currently using insulin.
  • History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.
  • History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.
  • History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding etc) or gastrointestinal procedures for weight loss (including LAP-BAND®), or uncontrolled gastrointestinal disorders at Screening (e.g., peptic ulcer, gastroesophageal reflux disease).

Treatment and study plan

PG-102(MG12)

Drug

GLP-1 and GLP-2 fusion protein

Placebo

Other

Placebo drug of PG-102(MG12)

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs) for Part A

    Time frame: Baseline to Day 29

    Number of participants with treatment-emergent adverse events (TEAEs)

  2. Number of participants with treatment-emergent adverse events (TEAEs) for Part B

    Time frame: Baseline to Day 57

    Number of participants with treatment-emergent adverse events (TEAEs)

  3. Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A

    Time frame: Baseline to Day 29

    Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0

  4. Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B

    Time frame: Baseline to Day 57

    Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0

  5. Number of participants with clinically significant abnormalities in vital signs for Part A

    Time frame: Baseline to Day 29

    Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)

  6. Number of participants with clinically significant abnormalities in vital signs for Part B

    Time frame: Baseline to Day 57

    Blood pressure (mmHg), Respiration (breathing) rate per minute, Body temperature (Celsius)

  7. Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A

    Time frame: Baseline to Day 29

    Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)

  8. Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B

    Time frame: Baseline to Day 57

    Ventricular rate (bpm), PR interval (msec), QRSD (msec), QT (msec), QTc (msec)

Secondary outcomes

  1. Maximum plasma concentration (Cmax) for Part A

    Time frame: Baseline to Day 29

    Maximum plasma concentration (Cmax)

  2. Maximum plasma concentration (Cmax) for Part B

    Time frame: Baseline to Day 57

    Maximum plasma concentration (Cmax)

  3. Time to maximum plasma concentration (tmax) for Part A

    Time frame: Baseline to Day 29

    Time to maximum plasma concentration (tmax)

  4. Time to maximum plasma concentration (tmax) for Part B

    Time frame: Baseline to Day 57

    Time to maximum plasma concentration (tmax)

  5. Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A

    Time frame: Baseline to Day 29

    Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)

  6. Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B

    Time frame: Baseline to Day 57

    Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t)

  7. Terminal half-life (t1/2) for Part A

    Time frame: Baseline to Day 29

    Terminal half-life (t1/2)

  8. Terminal half-life (t1/2) for Part B

    Time frame: Baseline to Day 57

    Terminal half-life (t1/2)

  9. Apparent total clearance (CL/F) for Part A

    Time frame: Baseline to Day 29

    Apparent total clearance (CL/F)

  10. Apparent total clearance (CL/F) for Part B

    Time frame: Baseline to Day 57

    Apparent total clearance (CL/F)

Sponsors and collaborators

Lead sponsor

ProGen. Co., Ltd.

Other

Registry information

Official study title

A Double-blind, Randomized, Placebo Controlled, Combined Single (Part A) and Multiple (Part B, C) Ascending Dose, Phase 1 Study to Investigate the Safety, Tolerability and Pharmacokinetic and Pharmacodynamics Following Subcutaneous Injections of PG-102(MG12) in Healthy Adult and Obesity Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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