Obesity & Metabolic Clinical Research · India
Obesity and Diabetes Clinical Trials in India, Including GLP-1 Studies
Shen Clinical Services runs obesity clinical trials in India, along with type 2 diabetes and metabolic studies, from Phase I to Phase IV. We support new GLP-1 and incretin therapies, generic and biosimilar peptides such as semaglutide, oral antidiabetics and cardiometabolic outcome studies, covering protocol design, CDSCO and ethics approvals, site selection, data management and safety reporting.
11.4%Of Indian adults have diabetes
28.6%Have generalised obesity
15.3%Have prediabetes
90 working daysCDSCO trial decision
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Why India
Why Run Obesity Clinical Trials in India
Metabolic disease is one of the fastest-growing areas of clinical research worldwide, and India has both the patients and the demand.
Large Patient Population
The ICMR-INDIAB study found diabetes in 11.4%, prediabetes in 15.3% and generalised obesity in 28.6% of Indian adults.
Fast-Growing Research Area
IQVIA reports that obesity and metabolic trial starts have risen more than five-fold over the past decade worldwide.
GLP-1 Generics in India
Indian companies launched generic semaglutide in March 2026, with at least one approval based on Phase III semaglutide clinical trials run in India.
Time-Bound Approvals
CDSCO decides on a trial application within 90 working days, or 30 working days for drugs discovered and developed in India.
Indications
Metabolic Indications and Endpoints We Cover
We design and run metabolic and GLP-1 clinical trials across these areas:
| Indication | Typical studies | Common endpoints |
|---|---|---|
| Obesity and overweight | GLP-1, dual and triple agonist, and oral weight management trials | Percent change in body weight; proportion losing at least 5%; waist circumference |
| Type 2 diabetes | New drugs, combinations and add-on therapy trials | Change in HbA1c; fasting plasma glucose; hypoglycaemia |
| Generic and biosimilar GLP-1 | Comparative Phase III and pharmacokinetic studies for semaglutide, liraglutide and similar peptides | HbA1c or weight change versus reference; PK; immunogenicity |
| Prediabetes | Prevention and progression studies | Conversion to diabetes; glucose tolerance |
| Cardiometabolic outcomes | Cardiovascular and kidney outcome trials | Three-point MACE; kidney function decline |
| Metabolic liver disease | MASLD and MASH studies | Liver fat on imaging; biopsy-based histology |
| Dyslipidaemia | Lipid-lowering trials | Percent change in LDL cholesterol |
Developing a recombinant GLP-1? See our biosimilar development services. For heart outcome studies, see cardiovascular clinical trials in India.
Trial Operations
How We Run GLP-1 Clinical Trials and Metabolic Studies
Metabolic studies need accurate measurements over many months and careful safety follow-up. We set up and manage:
- Endocrinology sites: diabetologists, endocrinologists and obesity clinics across India
- Standard measurements: calibrated scales, waist circumference and blood pressure at every visit
- Central laboratories: HbA1c, glucose, lipids and liver markers
- Dose escalation and GI tolerability: titration schedules and participant support to keep dropouts low
- Retention: visit reminders and diaries for long weight management studies
- Pathway strategy: new drug, generic or similar biologic route for peptide products
- Approvals: CDSCO permission in Form CT-04/CT-06, ethics approvals and CTRI registration
Learn more about our clinical trial protocol design and clinical data management services.
Our Process
How We Deliver Your Metabolic Trial
STEP 01
Feasibility and Sites
We check patient numbers and standard of care, then select endocrinology and obesity sites.
STEP 02
Protocol and Approvals
We write the protocol and file for CDSCO permission, ethics approvals and CTRI registration.
STEP 03
Conduct and Monitor
We start up sites and monitor enrolment, dose escalation, measurements and source data.
STEP 04
Data, Safety and Reports
We manage data, report serious adverse events on time and deliver the study report.
Why Shen
Why Choose Shen as Your Metabolic CRO in India
Physician-Led Oversight
Medically qualified team members review protocols, eligibility and safety signals throughout the study.
Regulatory Under One Roof
The same team handles CDSCO, ethics and CTRI filings and advises on the regulatory pathway for peptide products.
Endocrinology Site Network
We work with diabetologists, endocrinologists and obesity clinics across India.
One Partner, Full Service
Monitoring, data management, pharmacovigilance and medical writing from a single team.
What We Cover
Our Obesity and Diabetes Clinical Research Services
Feasibility and site selection
Protocol and study design
CDSCO trial permission
Ethics committee submissions
CTRI registration
Site start-up and monitoring
Central laboratory coordination
Generic and biosimilar GLP-1 studies
Clinical data management
Biostatistics
Pharmacovigilance and SAE reporting
Medical writing and CSRs
FAQs
Obesity and Diabetes Clinical Trials in India: Frequently Asked Questions
Why run obesity and diabetes clinical trials in India?
India has one of the world’s largest metabolic patient populations: the ICMR-INDIAB study found diabetes in 11.4%, prediabetes in 15.3% and generalised obesity in 28.6% of adults. Combined with a time-bound CDSCO approval process and mandatory CTRI registration, this supports fast enrolment for GLP-1, diabetes and weight management studies.
Do generic semaglutide or other GLP-1 products need clinical trials in India?
Often, yes. Generic semaglutide launched in India in March 2026, and at least one approval was based on Phase III clinical trials conducted in India and reviewed by CDSCO’s Subject Expert Committee. The data CDSCO needs depends on the product, its origin (synthetic or recombinant) and its indication, so the pathway should be agreed early.
What are the main endpoints in obesity trials?
Obesity drug trials usually measure percent change in body weight from baseline and the proportion of participants losing at least 5% of their weight, alongside waist circumference, blood pressure, lipids and quality of life. Longer studies may add cardiovascular outcomes.
What are the main endpoints in type 2 diabetes trials?
Type 2 diabetes trials usually use change in HbA1c as the primary endpoint, with fasting plasma glucose, body weight, hypoglycaemia rates and, for cardiovascular outcome trials, three-point MACE.
How long does CDSCO take to approve a metabolic trial?
Under Rule 22 of the New Drugs and Clinical Trials Rules, 2019, CDSCO decides on a clinical trial application within 90 working days. For drugs discovered in India, or researched and to be manufactured and marketed in India, Rule 23 sets 30 working days.
How are GI side effects managed in GLP-1 trials?
Nausea, vomiting and other gastrointestinal effects are common with GLP-1 drugs, so protocols use gradual dose escalation, clear participant guidance and close safety follow-up. Serious adverse events must be reported within 24 hours under Rule 42.
Resource Spotlight
Planning a broader programme? See our full range of clinical trial services in India and our biologics registration in India service.
Start Your Obesity or Diabetes Trial in India
Planning a GLP-1 or diabetes study? Share your protocol synopsis for a feasibility and budget estimate.
Developing a generic peptide? We can map the CDSCO pathway and run the comparative study.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: ICMR-INDIAB study, The Lancet Diabetes & Endocrinology (2023); IQVIA, therapeutic areas driving clinical trial growth (2026); Generic semaglutide launches in India (March 2026); New Drugs and Clinical Trials Rules, 2019 (CDSCO); Clinical Trials Registry – India. General regulatory information, not legal advice.