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New treatment option for Weight Management in Adult Patients With Obesity or Overweight
Official title Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
ClinicalTrials.gov ID: NCT07205432
What this study is testing
What is XTL6001?
XTL6001 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for weight management in adult patients with obesity or overweight.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects. SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- for people in SAD part:
- Age ≥ 18 and \< 65 years at screening.
- Body mass index (BMI) ≥ 18.5 kg/m² and \< 28.0 kg/m² at screening.
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
- Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions. for...
You likely can't join if
- Exclusion Criteria for people in SAD part:
- History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening.
- Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic...
- History of acute or chronic pancreatitis.
- Symptomatic gallbladder disease.
- Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
See the full eligibility criteria
- for people in SAD part:
- Age ≥ 18 and \< 65 years at screening.
- Body mass index (BMI) ≥ 18.5 kg/m² and \< 28.0 kg/m² at screening.
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
- Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions. for people in MAD part:
- Age ≥ 18 and \< 65 years at screening.
- BMI ≥ 18.5 kg/m2且 \< 40.0kg/m².
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
- Stable body weight (fluctuation \< 5%) for at least 3 months prior to screening.
- Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
- Exclusion Criteria for people in SAD part:
- History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening.
- Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.
- History of acute or chronic pancreatitis.
- Symptomatic gallbladder disease.
- Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
- Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
- Female people with positive pregnancy test or lactation. Exclusion Criteria for people in MAD part:
- History of type 1 or type 2 diabetes mellitus, or HbA1c \> 6.5% or fasting plasma glucose \> 7.0 mmol/L at screening.
- UnderlyingCushing's syndrome, hypothyroidism, PCOS,.
- Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or gastrointestinal surgeries that may compromise...
- History of acute or chronic pancreatitis.
- Symptomatic gallbladder disease.
- Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
- Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
- Female people with positive pregnancy test or lactation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.