Low-Dose Semaglutide for Weight Loss in Obese Non-Diabetic Pakistani Adults

Sponsor
Asian Institute Of Medical Sciences
Study ID
NCT07513168
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cardiometabolic Risk Factors
  • Obesity
  • Weight Reduction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This prospective, open-label, single-arm, single-center interventional pilot trial aims to evaluate the efficacy and safety of low-dose semaglutide for weight loss and cardiometabolic improvement in obese Pakistani adults without type 2 diabetes mellitus. The study will be conducted at the Asian Institute of Medical Sciences (AIMS), Hyderabad, Sindh, Pakistan. A total of 60 obese adults aged 18 years or older with a body mass index (BMI) of 27.5 kg/m² or greater according to World Health Organization Asian cutoffs and without type 2 diabetes mellitus (fasting blood glucose \<126 mg/dL and HbA1c \<6.5%) will be enrolled. Eligible participants will receive once-weekly subcutaneous semaglutide following a standard dose titration schedule of 0.25 mg weekly for four weeks, 0.5 mg weekly for four weeks, and 1.0 mg weekly for the remaining 16 weeks, for a total treatment duration of 24 weeks. All participants will receive standardized lifestyle counseling, including a hypocaloric diet with a 500-750 kcal/day deficit and at least 150 minutes per week of moderate-intensity physical activity. The primary outcome is the percentage change in body weight from baseline to 24 weeks. Secondary outcomes include changes in body mass index, waist circumference, systolic and diastolic blood pressure, lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides), liver enzymes (alanine aminotransferase and aspartate aminotransferase), and quality of life. Safety will be assessed through continuous monitoring of adverse events and adverse drug reactions with causality assessment using the Naranjo Adverse Drug Reaction Probability Scale. Clinical and laboratory assessments will be conducted at baseline, 12 weeks, and 24 weeks. Data will be analyzed using descriptive and inferential statistics, including paired t-tests or non-parametric equivalents and repeated measures analysis, with a significance level of p \< 0.05. The study will be conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki, with approval from the AIMS Institutional Review Board and written informed consent obtained from all participants. The trial aims to generate locally relevant clinical evidence on the effectiveness and safety of low-dose semaglutide for obesity management in non-diabetic Pakistani adults.

Key Dates

Start date
Aug 1, 2025
Status verified
Jul 2025
Primary completion
Aug 30, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low-Dose Semaglutide Intervention
    Participants in this single arm will receive once-weekly subcutaneous injections of locally available semaglutide (rDNA-based) for a total duration of 24 weeks (6 months). The intervention follows a standardized dose titration schedule to improve tolerability and minimize gastrointestinal adverse effects. All participants will receive standardized lifestyle counseling at baseline, month 3, and month 6, including guidance on a balanced hypocaloric diet (500-750 kcal/day deficit) and encouragement of moderate-intensity physical activity (≥150 minutes per week). No comparator or placebo arm is included in this single-arm design.

Primary Outcome Measure

Percentage Change in Body Weight [ Time Frame: Baseline to 24 weeks ]

Central Contacts

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