Clinical trial NCT06712615: Phase II Study of PG-102(MG12) Compared with Placebo in Obesity and Type 2 Diabetes
Official title: A Phase II Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Safety of PG-102(MG12) Compared with Placebo in Subjects with Obesity and in Subjects with Type 2 Diabetes Mellitus (T2DM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus (T2DM)
Obesity Type 2 Diabetes Mellitus
Lead sponsor: ProGen. Co., Ltd.
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 144
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase 2 clinical trial aims to evaluate the safety and efficacy of PG-102 (MG12) in patients with type 2 diabetes and obesity. The study is a randomized, double-blind, placebo-controlled, multi-center trial. Participants will be randomly assigned to receive either PG-102 or a placebo over a 12-week treatment period. The primary goal is to investigate the therapeutic potential of PG-102 in improving clinical outcomes for type 2 diabetes and obesity, while closely monitoring the safety profile of the treatment.

Detailed description: The study will be conducted in two parts, A and B, with a total of six cohorts. Part A will involve two cohorts comprising patients with type 2 diabetes, while Part B will include four cohorts of patients with obesity.

Part A (T2DM): In Part A, subjects with type 2 diabetes will receive multiple doses of the study drug over a 12-week period, with varying dosing schedules across the two cohorts, to evaluate the safety and efficacy of PG-102 (MG12).

Part B (OB): In Part B, subjects with obesity will receive multiple doses of the study drug over a 12-week period, with varying dosing schedules across the four cohorts to evaluate the safety and efficacy of PG-102 (MG12) in this subgroup. Cohort B2 will include subjects who are both obese and have type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 to 75 years who provide informed consent.

   \[Part A: Type 2 Diabetes Mellitus (T2DM) Specific Criteria\]
2. Diagnosed with type 2 diabetes for at least 6 months, with HbA1c between 7.0% and 10.0%, despite adherence to diet and exercise therapy according to diabetes treatment guidelines.
3. Stable on metformin monotherapy or metformin in combination with one oral hypoglycemic agent for at least 90 days.
4. BMI between 18.5 kg/m² and 30.0 kg/m², with a minimum weight of 55 kg for men and 50 kg for women.

   \[Part B: Obesity (OB) Specific Criteria\]
5. Failed at least one attempt at weight loss through diet and exercise.
6. Cohort B1: BMI ≥ 30 kg/m²
7. Cohort B2: BMI ≥ 27 kg/m² 8-1. Cohort B2: Diagnosed with type 2 diabetes for at least 6 months, with HbA1c between 7.0% and 10.0%.

8-2. Cohort B2: Received treatment with diet and exercise alone, OR stable on approved oral antidiabetic monotherapy or combination therapy for at least 90 days prior to screening.

Exclusion Criteria:

1. Participation in another clinical trial within 90 days.
2. Known hypersensitivity to study drugs or their components.
3. Inability to administer the drug in the abdomen.
4. History of severe gastrointestinal disorders, recent obesity-related surgeries, or conditions affecting gastric emptying.
5. Uncontrolled severe hypertension, hypertriglyceridemia, or severe cardiovascular disease.
6. History of acute pancreatitis, recent cancer, or endocrine disorders causing obesity.
7. Abnormal lab results, including eGFR \< 60 mL/min/1.73 m², AST/ALT \> 3x ULN, or abnormal ECG.
8. Substance abuse or significant psychiatric disorders within the last 2 years.
9. Pregnant, breastfeeding, or unwilling to use contraception during the study.

Primary outcomes:
measure: Change in Glycated Hemoglobin (HbA1c) in part A
timeFrame: Baseline at weeks 14
measure: Change in Glycated Hemoglobin (HbA1c) in Part B
timeFrame: Baseline at weeks 14
Secondary outcomes:
measure: Evaluation of treatment-emergent adverse events (TEAEs) in Part A
timeFrame: Baseline to weeks 20
measure: Percent Change in Fasting Plasma Glucose (FPG) from Baseline
timeFrame: Baseline at weeks 4, 8, 12, 14, 16, and 20
measure: Evaluation of treatment-emergent adverse events (TEAEs) in Part B.
timeFrame: Baseline to weeks 20
measure: Percent Change in Body Weight from Baseline
timeFrame: Baseline at weeks 4, 8, 12, 16, and 20
measure: Absolute Change in Body Weight from Baseline
timeFrame: Baseline at weeks 4, 8, 12, 14, 16, and 20
measure: Change in Glycated Hemoglobin (HbA1c) from Baseline (Cohort B2)
timeFrame: Baseline at weeks 4, 8, 12, 14, 16, and 20
measure: Percent Change in Fasting Plasma Glucose (FPG) from Baseline (Cohort B2)
timeFrame: Baseline at weeks 4, 8, 12, 14, 16, and 20
measure: Absolute Change in Fasting Plasma Glucose (FPG) from Baseline (Cohort B2)
timeFrame: Baseline at weeks 4, 8, 12, 14, 16, and 20
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital, Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: KOREA University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: KOREA University Asan Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University, Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of KOREA, Seoul St.Mary's Hostital
city: Sungnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: KOREA University Anam Hospital, Seoul, South Korea
name: Sin Gon Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: KOREA University Asan Hospital in Korea
name: Nan Hee Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital in Korea
name: Soo Lim Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of KOREA, Seoul St.Mary's Hostital in Korea
name: Seung-Hwan Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hostital in Korea
name: Yong-Ho Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of KOREA, Yeouido St.Mary's Hostital in Korea
name: Hyuk-Sang Kwon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of KOREA, Bucheon St.Mary's Hostital in Korea
name: Jang Won Son, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee University, Medical Center in Korea
name: Sang Youl Rhee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee University Hospital at Gangdong in Korea
name: In Kyung Jeong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangbuk Samsung Hospital, Samsung Medical Center in Korea
name: Jae-Heon Kang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center in Korea
name: Jae Hyeon Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nowon Eul Ji Medical Center, Eul Ji University in Korea
name: Kyung Wan Min, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daejeon Eul Ji Medical Center, Eul Ji University in Korea
name: Jun Hwa Hong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeungnam University Medical Center in Korea
name: Kyu Chang Won, MD
role: PRINCIPAL_INVESTIGATOR
References: