ObesityPhase 4NCT07513168
Low-Dose Semaglutide for Weight Loss in Obese Non-Diabetic Pakistani Adults
A Phase 4 study testing Locally available low-dose semaglutide (0.25 mg, 0.5 mg, 1 mg) in people with Obesity and Weight Reduction, run by Asian Institute Of Medical Sciences at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Weight Reduction, Cardiometabolic Risk Factors
- What is being tested?
- Locally available low-dose semaglutide (0.25 mg, 0.5 mg, 1 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Asian Institute of Medical Sciences
Hyderābād, Sindh, 71000
Sadik Memon Dr, +923009373868, sadikmemon@gmail.com
Haris Rathore, +923138189653, aimshyd786@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Weight Reduction, Cardiometabolic Risk Factors
- Being tested
- Locally available low-dose semaglutide (0.25 mg, 0.5 mg, 1 mg)
- Keywords
- Semaglutide, Obesity, Weight loss, GLP-1 Receptor Agonist, Body Mass Index, Open label trial, Cardiometabolic risk, Single Arm Study, Pakistan, Obesity Pharmacotherapy
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locally available low-dose semaglutide (0.25 mg, 0.5 mg, 1 mg)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Semaglutide Intervention | Experimental | 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. Receives: Drug: Locally available low-dose semaglutide (0.25 mg, 0.5 mg, 1 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Body Weight
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.
Measured: Baseline to 24 weeks
Secondary outcomes (5)
Change in Body Mass Index (BMI)
The change in BMI from baseline to 24 weeks will be calculated to assess the impact of semaglutide treatment on overall body composition.
Measured: Baseline, 12 weeks, and 24 weeks
Change in Waist Circumference
Waist circumference will be measured using standardized techniques to evaluate reduction in central adiposity during the 24-week intervention period.
Measured: Baseline, 12 weeks, and 24 weeks
Change in Lipid Profile
Fasting blood samples will be analyzed for total cholesterol, LDL-C, HDL-C, and triglycerides to evaluate changes in lipid parameters during the study.
Measured: Baseline, 12 weeks, and 24 weeks
Change in Liver Enzymes
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels will be measured to monitor hepatic safety and assess potential metabolic improvements.
Measured: Baseline, 12 weeks, and 24 weeks
Safety and Adverse Drug Reactions
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.
Measured: Continous throughout 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Aug 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label, single-center interventional study designed to evaluate the efficacy and safety of low-dose semaglutide in obese Pakistani adults without type 2 diabetes. All participants will receive the same intervention (once-weekly subcutaneous semaglutide with dose titration: 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, and 1.0 mg for 16 weeks) along with standardized lifestyle counseling. There is no control or comparator group, and participants are aware of the intervention. The study aims to assess weight loss, cardiometabolic parameters, quality of life, and safety over a 24-week period. Data will be collected at baseline, 12 weeks, and 24 weeks, with continuous adverse event monitoring. This design allows preliminary evaluation of treatment effect and safety in a real-world local population.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad sadik memon, Asian Institute Of Medical Sciences
- Investigators
- Dr. Fatima Nadeem, Study director, Asian Institute Of Medical SciencesSadik Memon, Principal investigator, Asian Institute Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513168
- Sponsor's protocol ID
- AIMS/ERC/9856/26
- Status last verified
- Jul 2025
- First submitted
- 1 Apr 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Adverse Drug Reaction Probability Scale (Naranjo) in Drug Induced Liver Injury. 2019 May 4. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK548069/
PubMed 31689026Hammad MAM, Quesada SG, Belczyk AL, Ghoniem GM. Beyond Glycemic Control: Concurrent GLP-1 Receptor Agonist Use Is Associated with Reduced Urinary Adverse Events Following OnabotulinumtoxinA Treatment in Non-Diabetic Adults with Overactive Bladder. Toxins (Basel). 2025 Nov 1;17(11):542. doi: 10.3390/toxins17110542.
PubMed 41295856Sterckx M, De Keyser L. Euglycemic Ketoacidosis Following the Use of Counterfeit Semaglutide for Weight Loss. Cureus. 2026 Jan 30;18(1):e102627. doi: 10.7759/cureus.102627. eCollection 2026 Jan.
PubMed 41773123Ismaiel A, Scarlata GGM, Boitos I, Leucuta DC, Popa SL, Al Srouji N, Abenavoli L, Dumitrascu DL. Gastrointestinal adverse events associated with GLP-1 RA in non-diabetic patients with overweight or obesity: a systematic review and network meta-analysis. Int J Obes (Lond). 2025 Oct;49(10):1946-1957. doi: 10.1038/s41366-025-01859-6. Epub 2025 Aug 13.
PubMed 40804463Kasagga A, Rebellow D, Hashmi T, Husami MY, Lama P, Arul Selvan K, Nakasagga K. Comparative Efficacy and Tolerability of Tirzepatide Versus Semaglutide at Varying Doses for Weight Loss in Non-diabetic Adults With Obesity: A Network Meta-Analysis of Randomized Controlled Trials. Cureus. 2025 Aug 17;17(8):e90335. doi: 10.7759/cureus.90335. eCollection 2025 Aug.
PubMed 40978842Quddos F, Hubshman Z, Tegge A, Sane D, Marti E, Kablinger AS, Gatchalian KM, Kelly AL, DiFeliceantonio AG, Bickel WK. Semaglutide and Tirzepatide reduce alcohol consumption in individuals with obesity. Sci Rep. 2023 Nov 28;13(1):20998. doi: 10.1038/s41598-023-48267-2.
PubMed 38017205Ard J, Fitch A, Fruh S, Herman L. Weight Loss and Maintenance Related to the Mechanism of Action of Glucagon-Like Peptide 1 Receptor Agonists. Adv Ther. 2021 Jun;38(6):2821-2839. doi: 10.1007/s12325-021-01710-0. Epub 2021 May 11.
PubMed 33977495Thomsen RW, Mailhac A, Lohde JB, Pottegard A. Real-world evidence on the utilization, clinical and comparative effectiveness, and adverse effects of newer GLP-1RA-based weight-loss therapies. Diabetes Obes Metab. 2025 Apr;27 Suppl 2(Suppl 2):66-88. doi: 10.1111/dom.16364. Epub 2025 Apr 8.
PubMed 40196933European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024 Sep;81(3):492-542. doi: 10.1016/j.jhep.2024.04.031. Epub 2024 Jun 7.
PubMed 38851997Rodriguez PJ, Goodwin Cartwright BM, Gratzl S, Brar R, Baker C, Gluckman TJ, Stucky NL. Semaglutide vs Tirzepatide for Weight Loss in Adults With Overweight or Obesity. JAMA Intern Med. 2024 Sep 1;184(9):1056-1064. doi: 10.1001/jamainternmed.2024.2525.
PubMed 38976257Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831.
PubMed 33625476Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.
PubMed 35441470Tan HC, Dampil OA, Marquez MM. Efficacy and Safety of Semaglutide for Weight Loss in Obesity Without Diabetes: A Systematic Review and Meta-Analysis. J ASEAN Fed Endocr Soc. 2022;37(2):65-72. doi: 10.15605/jafes.037.02.14. Epub 2022 Aug 23.
PubMed 36578889Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D; STEP 4 Investigators. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1414-1425. doi: 10.1001/jama.2021.3224.
PubMed 33755728Singh G, Krauthamer M, Bjalme-Evans M. Wegovy (semaglutide): a new weight loss drug for chronic weight management. J Investig Med. 2022 Jan;70(1):5-13. doi: 10.1136/jim-2021-001952. Epub 2021 Oct 27.
PubMed 34706925
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07513168
- Acronym / sponsor ID
- AIMS/ERC/9856/26
- Conditions
- Obesity, Weight Reduction, Cardiometabolic Risk Factors
- Keywords
- Semaglutide, Obesity, Weight loss, GLP-1 Receptor Agonist, Body Mass Index, Open label trial, Cardiometabolic risk, Single Arm Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asian Institute Of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label, single-center interventional study designed to evaluate the efficacy and safety of low-dose semaglutide in obese Pakistani adults without type 2 diabetes. All participants will receive the same intervention (once-weekly subcutaneous semaglutide with dose titration: 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, and 1.0 mg for 16 weeks) along with standardized lifestyle counseling. There is no control or comparator group, and participants are aware of the intervention. The study aims to assess weight loss, cardiometabolic parameters, quality of life, and safety over a 24-week period. Data will be collected at baseline, 12 weeks, and 24 weeks, with continuous adverse event monitoring. This design allows preliminary evaluation of treatment effect and safety in a real-world local population.
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Semaglutide Intervention | Experimental | Drug: Locally available low-dose semaglutide (0.25 mg, 0.5 mg, 1 mg)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Low-Dose Semaglutide Intervention |
Primary outcome
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.
5 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline, 12 weeks, and 24 weeks
Change in Waist Circumference
Time frame: Baseline, 12 weeks, and 24 weeks
Change in Lipid Profile
Time frame: Baseline, 12 weeks, and 24 weeks
Change in Liver Enzymes
Time frame: Baseline, 12 weeks, and 24 weeks
Safety and Adverse Drug Reactions
Time frame: Continous throughout 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 31689026Adverse Drug Reaction Probability Scale (Naranjo) in Drug Induced Liver Injury. 2019 May 4. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK548069/
- Background: PubMed 41295856Hammad MAM, Quesada SG, Belczyk AL, Ghoniem GM. Beyond Glycemic Control: Concurrent GLP-1 Receptor Agonist Use Is Associated with Reduced Urinary Adverse Events Following OnabotulinumtoxinA Treatment in Non-Diabetic Adults with Overactive Bladder. Toxins (Basel). 2025 Nov 1;17(11):542. doi: 10.3390/toxins17110542.
- Background: PubMed 41773123Sterckx M, De Keyser L. Euglycemic Ketoacidosis Following the Use of Counterfeit Semaglutide for Weight Loss. Cureus. 2026 Jan 30;18(1):e102627. doi: 10.7759/cureus.102627. eCollection 2026 Jan.
- Background: PubMed 40804463Ismaiel A, Scarlata GGM, Boitos I, Leucuta DC, Popa SL, Al Srouji N, Abenavoli L, Dumitrascu DL. Gastrointestinal adverse events associated with GLP-1 RA in non-diabetic patients with overweight or obesity: a systematic review and network meta-analysis. Int J Obes (Lond). 2025 Oct;49(10):1946-1957. doi: 10.1038/s41366-025-01859-6. Epub 2025 Aug 13.
- Background: PubMed 40978842Kasagga A, Rebellow D, Hashmi T, Husami MY, Lama P, Arul Selvan K, Nakasagga K. Comparative Efficacy and Tolerability of Tirzepatide Versus Semaglutide at Varying Doses for Weight Loss in Non-diabetic Adults With Obesity: A Network Meta-Analysis of Randomized Controlled Trials. Cureus. 2025 Aug 17;17(8):e90335. doi: 10.7759/cureus.90335. eCollection 2025 Aug.
- Background: PubMed 38017205Quddos F, Hubshman Z, Tegge A, Sane D, Marti E, Kablinger AS, Gatchalian KM, Kelly AL, DiFeliceantonio AG, Bickel WK. Semaglutide and Tirzepatide reduce alcohol consumption in individuals with obesity. Sci Rep. 2023 Nov 28;13(1):20998. doi: 10.1038/s41598-023-48267-2.
- Background: PubMed 33977495Ard J, Fitch A, Fruh S, Herman L. Weight Loss and Maintenance Related to the Mechanism of Action of Glucagon-Like Peptide 1 Receptor Agonists. Adv Ther. 2021 Jun;38(6):2821-2839. doi: 10.1007/s12325-021-01710-0. Epub 2021 May 11.
- Background: PubMed 40196933Thomsen RW, Mailhac A, Lohde JB, Pottegard A. Real-world evidence on the utilization, clinical and comparative effectiveness, and adverse effects of newer GLP-1RA-based weight-loss therapies. Diabetes Obes Metab. 2025 Apr;27 Suppl 2(Suppl 2):66-88. doi: 10.1111/dom.16364. Epub 2025 Apr 8.
- Background: PubMed 38851997European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024 Sep;81(3):492-542. doi: 10.1016/j.jhep.2024.04.031. Epub 2024 Jun 7.
- Background: PubMed 38976257Rodriguez PJ, Goodwin Cartwright BM, Gratzl S, Brar R, Baker C, Gluckman TJ, Stucky NL. Semaglutide vs Tirzepatide for Weight Loss in Adults With Overweight or Obesity. JAMA Intern Med. 2024 Sep 1;184(9):1056-1064. doi: 10.1001/jamainternmed.2024.2525.
- Background: PubMed 33625476Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O'Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT; STEP 3 Investigators. Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity: The STEP 3 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1403-1413. doi: 10.1001/jama.2021.1831.
- Background: PubMed 35441470Wilding JPH, Batterham RL, Davies M, Van Gaal LF, Kandler K, Konakli K, Lingvay I, McGowan BM, Oral TK, Rosenstock J, Wadden TA, Wharton S, Yokote K, Kushner RF; STEP 1 Study Group. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564. doi: 10.1111/dom.14725. Epub 2022 May 19.
- FDA press release announcing approval of Wegovy (semaglutide 2.4 mg weekly) for chronic weight management in adults with obesity or overweight plus ≥1 weight-related condition, based on trials showing significant weight loss with lifestyle intervention.Link provided by the sponsor.
- Classic article describing the Naranjo Adverse Drug Reaction Probability Scale, a validated method to estimate likelihood of drug-related adverse events, widely used in clinical research and pharmacovigilance to assess causality of reported reactions.Link provided by the sponsor.
- World Health Organization fact sheet on obesity and overweight, summarizing global prevalence, risk factors, health consequences, and public health impact of excess body weight across all regions, including data to support rationale for obesity managemenLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Fatima Nadeem study director
Asian Institute Of Medical Sciences
Sadik Memon principal investigator
Asian Institute Of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Locally available low-dose semaglutide (0.25 mg, 0.5 mg, 1 mg) in people with Obesity and Weight Reduction, run by Asian Institute Of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatima Nadeem Dr, Pharm-D, Mphil (+923080744996, fatima.nadeem2401@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Body Weight (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07513168, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.