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

April 1, 2026 updated by: Mohammad sadik memon, Asian Institute Of Medical Sciences

Efficacy and Safety of Low-Dose Semaglutide for Weight Loss and Cardiometabolic Improvement in Obese Pakistani Adults Without Type 2 Diabetes: A Single-Arm Open-Label Single-Center Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity is a growing public health concern worldwide and is increasingly prevalent in Pakistan, contributing significantly to cardiovascular disease, metabolic syndrome, non-alcoholic fatty liver disease, hypertension, dyslipidemia, and reduced quality of life. Despite the rising burden of obesity in South Asian populations, access to evidence-based pharmacological treatment remains limited, and locally generated clinical data on anti-obesity medications in non-diabetic individuals are scarce. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has demonstrated significant weight reduction and cardiometabolic benefits in multiple international clinical trials; however, most available evidence comes from Western populations and higher-dose formulations. In Pakistan, locally available lower-dose semaglutide formulations are increasingly being used in clinical practice, but their real-world effectiveness and safety in non-diabetic obese adults have not been systematically evaluated. This study aims to generate locally relevant clinical evidence to support the safe and effective use of semaglutide for obesity management in the Pakistani population.

This prospective, open-label, single-arm, single-center pilot interventional trial will be conducted at the Asian Institute of Medical Sciences (AIMS), Hyderabad, Sindh, Pakistan. The study will enroll 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, confirmed by fasting blood glucose less than 126 mg/dL and HbA1c less than 6.5% within three months prior to enrollment. Participants with a history of pancreatitis, medullary thyroid carcinoma, multiple endocrine neoplasia type 2, pregnancy or lactation, severe renal or hepatic impairment, current use of other anti-obesity medications, or known hypersensitivity to semaglutide will be excluded to ensure participant safety and minimize confounding factors.

Eligible participants will receive once-weekly subcutaneous low-dose semaglutide following a standardized dose titration schedule consisting of 0.25 mg weekly for the first four weeks, 0.5 mg weekly for the next four weeks, and 1.0 mg weekly for the remaining 16 weeks, for a total treatment duration of 24 weeks (six months). The medication will be administered under medical supervision, and participants will be educated on proper injection technique and adherence to the treatment regimen. In addition to pharmacological treatment, all participants will receive standardized lifestyle counseling, including a hypocaloric diet with a daily caloric deficit of 500-750 kcal and at least 150 minutes of moderate-intensity physical activity per week, in accordance with international obesity management guidelines.

The primary objective of the study is to evaluate the percentage change in body weight from baseline to 24 weeks following low-dose semaglutide treatment. Secondary objectives include evaluating changes in body mass index, waist circumference, systolic and diastolic blood pressure, lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, and triglycerides), liver enzymes (alanine aminotransferase and aspartate aminotransferase), and quality of life over the study period. Safety and tolerability 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 to evaluate treatment response and safety outcomes.

Data will be collected using standardized case report forms and securely stored in a password-protected database. Statistical analysis will be performed using IBM SPSS Statistics software. Descriptive statistics will summarize baseline demographic and clinical characteristics. Continuous variables will be expressed as mean with standard deviation or median with interquartile range, and categorical variables will be expressed as frequencies and percentages. Changes in primary and secondary outcomes from baseline to follow-up visits will be analyzed using paired t-tests or non-parametric equivalents depending on data distribution, and repeated measures analysis will be used to assess trends across time points. A p-value of less than 0.05 will be considered statistically significant. As a pilot trial, the sample size of 60 participants is intended to assess feasibility, estimate treatment effect, and generate preliminary data for future multicenter randomized controlled trials.

The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval will be obtained from the Institutional Review Board of the Asian Institute of Medical Sciences prior to study initiation. Written informed consent will be obtained from all participants before enrollment, and participant confidentiality will be maintained through de-identification and secure data handling. The results of this study are expected to provide important real-world clinical evidence on the effectiveness and safety of low-dose semaglutide for obesity management in non-diabetic Pakistani adults and support future larger-scale clinical research in the region.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Hyderābād, Sindh, Pakistan, 71000
        • Recruiting
        • Asian Institute of Medical Sciences
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dr. Fatima Nadeem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Body mass index (BMI ≥ 27.5 kg/m²) according to WHO Asian cut-offs.
  • No diagnosis of type 2 diabetes mellitus, confirmed by:

Fasting blood glucose < 126 mg/dL, and HbA1c < 6.5% within three months prior to enrollment.

  • Willingness and ability to provide written informed consent.
  • Willingness to comply with study procedures, including weekly injections and lifestyle counseling.

Exclusion Criteria:

  • History of pancreatitis.
  • History or presence of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2).
  • Pregnant or lactating women.
  • Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or hepatic impairment (ALT or AST > 3× upper limit of normal).
  • Current use of other anti-obesity medications.
  • Known hypersensitivity to semaglutide or any component of the formulation.
  • Any condition that, in the investigator's opinion, would interfere with participation, adherence, or safety in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Locally available low-dose semaglutide (0.25 mg, 0.5 mg, 1 mg)
Once-weekly subcutaneous injections following a titration schedule (0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for remaining 16 weeks) for a total of 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Body Weight
Time Frame: Baseline to 24 weeks
The primary outcome is the percentage change in body weight from baseline to 24 weeks following once-weekly low-dose semaglutide treatment. Body weight will be measured using standardized calibrated scales at baseline, 12 weeks, and 24 weeks. The outcome will assess the efficacy of semaglutide in reducing weight in obese adults without type 2 diabetes mellitus.
Baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI)
Time Frame: Baseline, 12 weeks, and 24 weeks
The change in BMI from baseline to 24 weeks will be calculated to assess the impact of semaglutide treatment on overall body composition.
Baseline, 12 weeks, and 24 weeks
Change in Waist Circumference
Time Frame: Baseline, 12 weeks, and 24 weeks
Waist circumference will be measured using standardized techniques to evaluate reduction in central adiposity during the 24-week intervention period.
Baseline, 12 weeks, and 24 weeks
Change in Lipid Profile
Time Frame: Baseline, 12 weeks, and 24 weeks
Fasting blood samples will be analyzed for total cholesterol, LDL-C, HDL-C, and triglycerides to evaluate changes in lipid parameters during the study.
Baseline, 12 weeks, and 24 weeks
Change in Liver Enzymes
Time Frame: Baseline, 12 weeks, and 24 weeks
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels will be measured to monitor hepatic safety and assess potential metabolic improvements.
Baseline, 12 weeks, and 24 weeks
Safety and Adverse Drug Reactions
Time Frame: Continous throughout 24 weeks
All adverse events and adverse drug reactions will be recorded and assessed using the Naranjo Adverse Drug Reaction Probability Scale to monitor tolerability and safety of low-dose semaglutide.
Continous throughout 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute Of Medical Sciences

Investigators

  • Study Director: Dr. Fatima Nadeem, Asian Institute of Medical Sciences
  • Principal Investigator: Sadik Memon, Asian Institute of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIMS/ERC/9856/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data will be shared with qualified researchers upon reasonable request, starting 6 months after primary study publication for a period of 5 years. Shared data will include participant demographics, body weight, BMI, waist circumference, laboratory results, blood pressure, quality of life outcomes, and safety data. Supporting documents available for sharing include the study protocol, statistical analysis plan, informed consent form, and analytic code. Data requests must include a research proposal and data-sharing agreement approved by the AIMS Institutional Review Board. Participant confidentiality will be maintained through removal of all personal identifiers.

IPD Sharing Time Frame

Start Date: Waiting 6 months after publication ensures that the primary investigators have time to finalize and publish the main study results before sharing data.

End Date: A 5-year period allows other qualified researchers sufficient time to request and use the de-identified data.

IPD Sharing Access Criteria

De-identified individual participant data will be available to qualified researchers with a scientific proposal and an approved data-sharing agreement from the AIMS Institutional Review Board. Shared data include baseline demographics, weight, BMI, waist circumference, blood pressure, lipid profile, liver enzymes, quality of life scores, and adverse events. Supporting documents include the study protocol, statistical analysis plan, informed consent form, and analytic code. Personal identifiers will be removed. Data will be shared electronically via secure file transfer or password-protected cloud after approval, for research purposes only. Access will begin 6 months after publication and continue for 5 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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