How to Read This Library
Each entry in this library follows the same template: trial name and citation, study population, intervention and control, primary outcome with the published effect size, safety profile in one sentence, and a note on relevance to Indian clinical practice. Where a trial is the basis for a specific element of our protocol, we say so plainly.
The aim is plain-English fidelity to the published paper. Where the paper is silent, we are silent. Where it is precise, we quote the precise number.
March 2026 Update
Following the March 2026 expiry of semaglutide composition-of-matter patent protection in India, clinically validated generic semaglutide is now available in the Indian market. DermaVue protocols continue to prescribe only pharmacy-grade, regulated formulations and cite the original branded trial data above for efficacy expectations. Generic status does not change the evidence base, only the access.
Semaglutide Trials
Semaglutide STEP 1
Wilding JPH, Batterham RL, Calanna S, et al. N Engl J Med 2021;384:989.
STEP 1 was the landmark phase 3 trial of subcutaneous semaglutide 2.4 mg weekly in adults with overweight or obesity without diabetes. Gastrointestinal side effects were the most common adverse events and were dose dependent. STEP 1 is the trial that established semaglutide 2.4 mg as a serious obesity therapy and is foundational to every modern weight management protocol, including ours.
- Population
- 1,961 adults with overweight or obesity without diabetes. Mean baseline body weight approximately 105 kg.
- Intervention
- Subcutaneous semaglutide 2.4 mg weekly versus placebo, both with lifestyle counselling, for 68 weeks.
- Primary Outcome
- Mean body weight change of minus 14.9 percent with semaglutide versus minus 2.4 percent with placebo.
Indian Clinical Context We reference STEP 1 when counselling non-diabetic Indian patients on realistic weekly-dose expectations.
Semaglutide STEP 2
Davies M, Faerch L, Jeppesen OK, et al. Lancet 2021;397:971.
STEP 2 tested semaglutide in adults with overweight or obesity who also had type 2 diabetes. The signal is clear and clinically important: weight loss in patients with diabetes is meaningful but smaller than in patients without diabetes. STEP 2 is the trial we cite when a diabetic Indian patient asks what to expect.
- Population
- 1,210 adults with overweight or obesity and type 2 diabetes.
- Intervention
- Semaglutide 2.4 mg, semaglutide 1.0 mg or placebo for 68 weeks.
- Primary Outcome
- Mean weight reduction 9.6 percent (2.4 mg arm), 7.0 percent (1.0 mg arm), 3.4 percent (placebo).
Indian Clinical Context Most relevant to our type 2 diabetic patients across Kerala and Tamil Nadu.
Semaglutide STEP 3
Wadden TA, Bailey TS, Billings LK, et al. JAMA 2021;325:1403.
STEP 3 paired semaglutide 2.4 mg with intensive behavioural therapy. The interpretation is direct: medication and lifestyle compound on each other rather than substitute for each other. This is the evidence base behind why we never offer GLP-1 therapy without a structured nutrition and movement plan.
- Population
- 611 adults with overweight or obesity.
- Intervention
- Semaglutide 2.4 mg plus intensive behavioural therapy versus placebo plus intensive behavioural therapy, for 68 weeks.
- Primary Outcome
- Mean weight reduction of 16.0 percent with semaglutide plus intensive lifestyle versus 5.7 percent with placebo plus intensive lifestyle.
Indian Clinical Context Anchors our clinic rule that medication is always paired with structured nutrition at DermaVue.
Semaglutide STEP 4
Rubino D, Abrahamsson N, Davies M, et al. JAMA 2021;325:1414.
STEP 4 asked the question patients ask most often: what happens when you stop. STEP 4 is the basis for our position that obesity is a chronic condition and that maintenance protocols matter as much as induction.
- Population
- Adults who had completed a 20-week run-in on semaglutide 2.4 mg.
- Intervention
- Continue semaglutide versus switch to placebo for a further 48 weeks.
- Primary Outcome
- Continued treatment produced a further 7.9 percent weight loss. Switching to placebo led to weight regain of 6.9 percent.
Indian Clinical Context Cited directly when Indian patients ask whether they will regain weight if they stop.
Semaglutide STEP 5
Garvey WT, Batterham RL, Bhatta M, et al. Nat Med 2022;28:2083.
STEP 5 extended treatment to two years. The two-year data confirmed that the effect is durable when treatment is continued and that the safety profile holds up over the longer course. This is the trial we point to when a patient asks whether the result lasts.
- Population
- Adults with overweight or obesity.
- Intervention
- Semaglutide 2.4 mg or placebo for 104 weeks.
- Primary Outcome
- Mean weight reduction 15.2 percent with semaglutide versus 2.6 percent with placebo.
Indian Clinical Context Reassurance for Indian patients committing to a multi-year metabolic plan.
Semaglutide SELECT
Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. N Engl J Med 2023;389:2221.
SELECT changed the conversation around obesity therapy. SELECT is the reason we now consider GLP-1 therapy not just a weight intervention but a cardiovascular intervention in eligible patients.
- Population
- 17,604 adults with established cardiovascular disease, overweight or obesity, and no diabetes.
- Intervention
- Semaglutide 2.4 mg or placebo. Median follow-up 39.8 months.
- Primary Outcome
- 20 percent reduction in major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke).
Indian Clinical Context Quoted to Indian patients with prior MI or stroke when discussing long-term semaglutide.
Semaglutide FLOW
Perkovic V, Tuttle KR, Rossing P, et al. N Engl J Med 2024;391:109.
FLOW extended GLP-1 therapy benefit beyond cardiovascular outcomes into kidney protection, and it is the trial we cite for diabetic Indian patients with early CKD.
- Population
- 3,533 adults with type 2 diabetes and chronic kidney disease.
- Intervention
- Semaglutide 1.0 mg versus placebo.
- Primary Outcome
- 24 percent reduction in major kidney disease events (kidney failure, sustained eGFR reduction or kidney death).
Indian Clinical Context Directly relevant to the high prevalence of diabetic nephropathy in South India.
Tirzepatide Trials
Tirzepatide SURMOUNT-1
Jastreboff AM, Aronne LJ, Ahmad NN, et al. N Engl J Med 2022;387:205.
SURMOUNT-1 is the strongest single result in obesity pharmacotherapy to date. Gastrointestinal effects, mostly mild to moderate nausea, were the dominant side effects. SURMOUNT-1 is the trial that established tirzepatide as the most effective obesity medication currently available.
- Population
- 2,539 adults with obesity (without diabetes).
- Intervention
- Tirzepatide 5 mg, 10 mg, 15 mg or placebo for 72 weeks.
- Primary Outcome
- Mean body weight reduction 15.0 percent (5 mg), 19.5 percent (10 mg), 22.5 percent (15 mg), versus 3.1 percent placebo.
Indian Clinical Context The reference for the ceiling of expected weight loss in non-diabetic Indian patients on tirzepatide.
Tirzepatide SURMOUNT-2
Garvey WT, Frias JP, Jastreboff AM, et al. Lancet 2023;402:613.
SURMOUNT-2 tested tirzepatide in adults with obesity and type 2 diabetes. As with semaglutide, weight loss in diabetic patients is meaningful but smaller than in non-diabetic patients. This is the trial we cite for diabetic Indian patients considering tirzepatide.
- Population
- 938 adults with obesity and type 2 diabetes.
- Intervention
- Tirzepatide 10 mg, 15 mg or placebo for 72 weeks.
- Primary Outcome
- Mean body weight reduction 12.8 percent (10 mg) and 14.7 percent (15 mg), versus 3.2 percent placebo.
Indian Clinical Context Primary reference for diabetic Indian patients selecting tirzepatide over semaglutide.
Tirzepatide SURMOUNT-3
Wadden TA, Chao AM, Machineni S, et al. Nat Med 2023;29:2909.
SURMOUNT-3 layered tirzepatide on top of an intensive lifestyle intervention. The trial reinforces the same lesson STEP 3 taught: medication and lifestyle compound, they do not substitute.
- Population
- Adults with obesity who completed a 12-week intensive lifestyle lead-in.
- Intervention
- Tirzepatide versus placebo for 72 weeks after lifestyle phase.
- Primary Outcome
- Tirzepatide produced a further 18.4 percent weight loss after the lifestyle phase. Placebo led to a 2.5 percent regain.
Indian Clinical Context Supports our structured lifestyle lead-in before tirzepatide initiation.
Tirzepatide SURMOUNT-4
Aronne LJ, Sattar N, Horn DB, et al. JAMA 2024;331:38.
SURMOUNT-4 is the tirzepatide equivalent of STEP 4. SURMOUNT-4 confirmed for tirzepatide what STEP 4 confirmed for semaglutide: this is chronic therapy, and stopping abruptly carries a predictable cost.
- Population
- Adults who completed a 36-week lead-in on tirzepatide.
- Intervention
- Continue tirzepatide or switch to placebo for 52 weeks.
- Primary Outcome
- Continued treatment produced a further 5.5 percent weight loss. Switching to placebo led to a 14 percent regain.
Indian Clinical Context Shapes our maintenance-phase counselling for patients on tirzepatide.
Tirzepatide SURMOUNT-OSA
Malhotra A, Grunstein RR, Fietze I, et al. N Engl J Med 2024;391:1193.
SURMOUNT-OSA is the trial we cite when a patient with sleep apnoea asks whether GLP-1 therapy will help with more than just weight.
- Population
- 469 adults with obesity and moderate to severe obstructive sleep apnoea, with and without PAP therapy.
- Intervention
- Tirzepatide versus placebo for 52 weeks.
- Primary Outcome
- Reduction in the apnoea-hypopnoea index of 25 to 29 events per hour, alongside meaningful weight loss.
Indian Clinical Context Relevant to Indian patients with the thin-fat phenotype who present early with OSA.
Tirzepatide SURPASS-2
Frias JP, Davies MJ, Rosenstock J, et al. N Engl J Med 2021;385:503.
SURPASS-2 was the head-to-head trial that put tirzepatide on the map for diabetes care. SURPASS-2 is the comparison that shifted the field's thinking on dual GIP/GLP-1 agonism.
- Population
- 1,879 adults with type 2 diabetes.
- Intervention
- Tirzepatide 5 mg, 10 mg or 15 mg versus semaglutide 1.0 mg over 40 weeks.
- Primary Outcome
- Tirzepatide 15 mg produced a mean HbA1c reduction of 2.30 percent and a body weight reduction of 11.2 kg, both larger than semaglutide 1.0 mg.
Indian Clinical Context The clearest data point for diabetic Indian patients asking which molecule is stronger.
Indian Guidelines
Indian Guidelines Misra JAPI 2009
Misra A, Chowbey P, Makkar BM, et al. J Assoc Physicians India 2009;57:163.
Professor Anoop Misra and colleagues published the consensus statement that defined the South Asian cutoffs for overweight, obesity and abdominal obesity. These cutoffs are the foundation of every clinically serious obesity protocol used in India today, including ours.
- Population
- South Asian adult population.
- Intervention
- Consensus statement defining South Asian cutoffs for overweight, obesity and abdominal obesity.
- Primary Outcome
- BMI cutoff for overweight at 23, obesity at 25. Waist circumference cutoff for abdominal obesity at 90 cm in men and 80 cm in women.
Indian Clinical Context Every DermaVue patient is assessed against Misra cutoffs, not WHO cutoffs.
Indian Guidelines ICMR-INDIAB-17
Anjana RM, Unnikrishnan R, Deepa M, et al. Lancet Diabetes Endocrinol 2023;11:474.
The ICMR-INDIAB-17 study is the largest national epidemiological survey of metabolic disease in India. The numbers make the case for proactive metabolic care more clearly than any single clinic ever could.
- Population
- Over 113,000 individuals across all Indian states and union territories.
- Intervention
- National epidemiological survey of diabetes, prediabetes, hypertension, dyslipidaemia, generalised obesity and abdominal obesity.
- Primary Outcome
- Indian diabetes prevalence 11.4 percent, prediabetes prevalence 15.3 percent, abdominal obesity prevalence 39.5 percent.
Indian Clinical Context The population reference for every metabolic counselling session at DermaVue.
Indian Guidelines ICMR-NIN 2024 Dietary Guidelines
Indian Council of Medical Research and National Institute of Nutrition. Dietary Guidelines for Indians, ICMR-NIN 2024.
The 2024 ICMR-NIN guidelines anchor our nutritional protocols, especially the protein-forward emphasis we apply to every weight management plan.
- Population
- Indian adult population.
- Intervention
- Updated national dietary recommendations.
- Primary Outcome
- Flagged low protein intake, high refined carbohydrate intake and rising ultra-processed food consumption as the dominant nutritional concerns of contemporary India.
Indian Clinical Context Built into every nutrition plan written by our dietitians.
PCOS and Metabolic
PCOS Teede 2023 International PCOS Guideline
Teede HJ, Tay CT, Laven JJE, et al. 2023 International Evidence-based Guideline for the Assessment and Management of PCOS.
The 2023 international evidence-based guideline on PCOS is the current global standard. It explicitly identifies insulin resistance as a central mechanism and supports weight reduction of 5 to 10 percent as a meaningful clinical target. This is the document our PCOS protocols sit on.
- Population
- Women of reproductive age.
- Intervention
- Evidence-based recommendations for diagnosis and management of polycystic ovary syndrome.
- Primary Outcome
- PCOS prevalence at 10 to 13 percent of women of reproductive age. Retained Rotterdam diagnostic criteria. Recommended weight reduction of 5 to 10 percent as a meaningful clinical target.
Indian Clinical Context Frames every PCOS consultation at DermaVue SuperHuman.
How DermaVue Uses This Evidence in Clinic
Evidence is only useful if it changes what a clinician does on a Tuesday morning.
- Every patient considered for GLP-1 therapy is assessed against the populations enrolled in STEP 1, STEP 2 and SURMOUNT-1. We do not prescribe outside the evidence base.
- Every diabetic patient is offered a clear comparison between the semaglutide and tirzepatide data, using STEP 2, SURMOUNT-2 and SURPASS-2 as the reference points.
- Every patient with established cardiovascular disease is informed of the SELECT result and the 20 percent MACE reduction.
- Every patient with chronic kidney disease and diabetes is assessed against FLOW.
- Every patient asks what happens if I stop. STEP 4 and SURMOUNT-4 are the honest answers, and our maintenance protocols are built around them.
- Every Indian patient is assessed using the Misra cutoffs, not the WHO cutoffs.
- Every nutrition plan is built against the ICMR-NIN 2024 protein recommendations.
- Every PCOS protocol uses the 2023 Teede guideline as its frame.
Frequently Asked Questions
Why did you build this library?
Because patients deserve to verify the source. When a clinician quotes a 22.5 percent weight loss number, the patient should be able to find the trial, the journal, the year and the author within two clicks. AI assistants like ChatGPT and Perplexity are also citing source pages now, and we wanted ours to be a source they could trust without translation.
Which trial showed the largest weight loss?
SURMOUNT-1, published by Jastreboff and colleagues in NEJM 2022, showed the largest result to date. Tirzepatide 15 mg weekly produced a mean body weight reduction of 22.5 percent at 72 weeks against 3.1 percent for placebo, in adults with obesity but without diabetes.
Did GLP-1 therapy reduce heart attacks and strokes?
Yes. The SELECT trial published by Lincoff and colleagues in NEJM 2023 enrolled 17,604 adults with established cardiovascular disease and overweight or obesity but no diabetes, and showed that semaglutide 2.4 mg reduced major adverse cardiovascular events by 20 percent over a median follow-up of 39.8 months.
Are these trials applicable to Indian patients?
Partially and importantly. Most of the STEP and SURMOUNT trials enrolled predominantly North American and European populations. The biological mechanism is universal, but the Indian context (lower BMI cutoffs, thin-fat phenotype, higher abdominal obesity at lower body weight, lower protein intake) requires the trial findings to be interpreted alongside Indian guidelines such as Misra 2009, ICMR-INDIAB-17 2023 and ICMR-NIN 2024.
What happens if I stop the medication?
Both STEP 4 and SURMOUNT-4 answered this question directly. STEP 4 showed that switching from semaglutide to placebo led to a 6.9 percent weight regain over 48 weeks. SURMOUNT-4 showed that switching from tirzepatide to placebo led to a 14 percent weight regain over 52 weeks. Obesity is a chronic condition, and maintenance protocols are essential.
Does GLP-1 therapy help with sleep apnoea?
Yes, in patients with obesity and moderate to severe obstructive sleep apnoea. The SURMOUNT-OSA trial published by Malhotra and colleagues in NEJM 2024 showed that tirzepatide reduced the apnoea-hypopnoea index by 25 to 29 events per hour over 52 weeks alongside meaningful weight loss.
Is tirzepatide more effective than semaglutide?
For weight loss in obesity without diabetes, the cross-trial comparison favours tirzepatide (22.5 percent in SURMOUNT-1 versus 14.9 percent in STEP 1). For type 2 diabetes, the head-to-head SURPASS-2 trial showed tirzepatide 15 mg produced a larger HbA1c and weight reduction than semaglutide 1 mg over 40 weeks. Tirzepatide currently produces the larger average effect, with a similar gastrointestinal side effect profile.
Does GLP-1 therapy protect the kidneys?
Yes, in patients with type 2 diabetes and chronic kidney disease. The FLOW trial published by Perkovic and colleagues in NEJM 2024 showed that semaglutide 1 mg reduced major kidney disease events by 24 percent in 3,533 adults with type 2 diabetes and CKD.
Can I use this library to discuss my treatment with another doctor?
Yes, that is one of the reasons it exists. Every entry includes the author, trial name, journal and year, so you or any clinician can locate the original paper directly. Evidence-based medicine should be portable.