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

Last updated: May 5, 2025
Sponsor: ProGen. Co., Ltd.
Overall Status: Completed

Phase

1

Condition

Obesity

Hypertriglyceridemia

Treatment

PG-102(MG12)

Placebo

Placebo

Clinical Study ID

NCT06309667
SL-MG12-P1
  • Ages 19-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent

  2. 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]

  1. 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.

  1. 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.

  2. History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.

  3. 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).

Study Design

Total Participants: 102
Treatment Group(s): 3
Primary Treatment: PG-102(MG12)
Phase: 1
Study Start date:
March 04, 2024
Estimated Completion Date:
February 05, 2025

Study Description

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.

Connect with a study center

  • Catholic University Seoul St.Mary Hospital,

    Seocho, Seoul 06591
    Korea, Republic of

    Site Not Available

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