CTRI/2025/08/093439招募中不适用
A Single Center, Randomized, Double Blind, Placebo Controlled, Interventional, Comparative, Clinical Study to evaluate the Efficacy and Safety of Feiolix Capsules in Prediabetic Participants.
Viridis BioPharma Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年9月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Mean change in Glycosylated hemoglobin (HbA1c) from baseline to Visit 5/Day 90±3.
研究概览
简要总结
A Single Center, Randomized, Double Blind, Placebo Controlled, Interventional, Comparative, Clinical Study to evaluate the Efficacy and Safety of Feiolix Capsules in Prediabetic Participants.
**Primary objective:**To evaluate the efficacy (in terms of HbA1c and GLP-1) of Feiolix Capsule in Prediabetic Participants.
**Secondary objective:**To evaluate the safety (based on AE and laboratory parameters) of Feiolix Capsule in PrediabeticParticipants.
**Standardized Breakfast:**A standardized breakfast will be provided to the participants on Visit 2/Day 1 and Visit 5/Day 90±3. Standardized breakfast equivalent to 524 kcal (63% from carbohydrates, 19% from proteins, 18% from fat).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and female participants, 20 to 65 years of age (both inclusive).
- •Participants with BMI greater than or equal to 25.00 and less than or equal to 29.9 kg/m2 at screening (overweight).
- •Participants with Glycosylated Hemoglobin (HbA1c) greater than or equal to 5.7 % and less than or equal to 6.4%.
- •Participants whose IDRS (Indian Diabetics Risk score) is less than or equal to
- •Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation.
- •Participants with type 1 or type 2 Diabetes mellitus (T2DM), gestational diabetes or secondary diabetes.
- •Participants on treatment with a glucose-lowering or weight loss agent (s) within 90 days before screening.
- •Participants with hypothyroidism or hyperthyroidism.
- •Participants with elevated liver enzymes AST and/or ALT more than 3 times the upper normal limit.
- •Participants with abnormal renal function as measured by eGFR less than 60 ml/min/1.73m
- •Participants who had bariatric surgery.
- •Participants with a significant change in usual diet and/or weight loss of more than 4.5 kg in the last 2 months.
- •Participants with a known history of chronic smoking, alcohol or drug abuse within the 12 months prior to screening.
- •Participants with a known history or ongoing malignancy.
- •Participants with any other co-morbidities necessitating medical care.
- •Participants who have undergone surgery in the last 6 months including but not limited to angioplasty, abdominal surgeries (including weight loss surgery) or partial/complete resection of stomach or bowel.
- •Participants with the presence or history of psychiatric illnesses, including eating disorders.
- •Participants with a family history of obesity.
- •Participants using phytoherbal supplements, dietary, nutraceuticals, allopathic, or ayurvedic supplements for weight loss or blood glucose management, supplements known to affect hunger/satiety/appetite/gut microbiome.
- •Any other health or mental condition or any significant laboratory parameters that in the investigators opinion may adversely affect the participants ability to complete the study or its measures or that may pose significant risk to the participant.
- •Female participants who are pregnant or lactating or planning to become pregnant during the study period.
- •Females or males who are not ready to use acceptable contraceptive methods during the course of study.
结局指标
主要结局
Mean change in Glycosylated hemoglobin (HbA1c) from baseline to Visit 5/Day 90±3.
时间窗: 90 Days
Mean change in appetite regulatory hormone [Glucagon-like peptide 1(GLP-1)] in fasting and post standardized breakfast – 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3.
时间窗: 90 Days
次要结局
- Mean change in blood sugar levels in fasting and post standardized breakfast – 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3.(90 Days)
- Mean change in appetite regulatory hormone (Glucagon and Ghrelin) in fasting and post standardized breakfast – 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3.(90 Days)
- Mean change in insulin resistance (Insulin) in fasting and post standardized breakfast – 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3.(90 Days)
- Mean change in insulin resistance (HOMA IR score) in fasting from Visit 2/Day 1 to Visit 5/Day 90±3.(90 Days)
- Mean change in fat metabolism (Lipid Profile) in fasting from Visit 2/Day 1 to Visit 5/Day 90±3.(90 Days)
- Mean change in anthropometric parameters (Body Weight, BMI and Waist Circumference) from baseline to Visit 3/Day 30±3, Visit 4/Day 60±3 and Visit 5/Day 90±3.(90 Days)
- Mean change in satiety (Visual Analog Scale for Satiety Assessment) post standardized breakfast – 30 minutes, 1 hour, 2 hours and 3 hours from Visit 2/Day 1 to Visit 5/Day 90±3.(90 Days)
- Safety Endpoint:(The assessment of safety of Investigational Product will be based on incidence of AEs, SAEs and changes in laboratory parameters.)
研究者
Dr Ashish Sarwate
Dr. Sarwates Diabetes Control and Foot Care Centre
研究点 (1)
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