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Fat LossStrong human clinical evidence FDA-approved label on file

Semaglutide

GLP-1 receptor agonist with extensive Phase 3 trial data for type 2 diabetes and chronic weight management. Prescription-only in most jurisdictions.

Educational only — not medical advice. SmartPeptide does not prescribe, diagnose, or treat. Always consult a licensed healthcare provider before using any peptide, supplement, medication, or protocol.

What the research shows

Strong Phase 3 evidence (STEP 1–8 trials). STEP-1 (n=1,961) showed ~14.9% body-weight reduction at 68 weeks vs ~2.4% placebo. SELECT trial (n=17,604) showed reduced major adverse cardiovascular events in overweight/obese adults without diabetes.

What's still experimental

Long-term effects beyond ~3–4 years of continuous use, optimal dosing for weight maintenance after stopping, and use in lean populations remain active research areas.

Anecdotal / community reports

Off-label dosing patterns, microdosing, and stacking with other GLP-1 analogs are widely discussed online but lack RCT support.

Anecdotal reports are NOT scientific evidence. They reflect personal experience and may not generalize.

FDA approval status

Source: openFDA + DailyMed (NIH/NLM)
6 FDA-approved labels on file· 8 on DailyMed
  • OZEMPIC
    (ORAL SEMAGLUTIDE) · Novo Nordisk Pharmaceutical Industries, LP
    Full label on DailyMed
    Indications & usage

    1 INDICATIONS AND USAGE RYBELSUS and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. RYBELSUS and OZEMPIC tablets are glucagon-like peptide-1 (GLP-1) receptor agonists indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these even…

    Dosage & administration

    2 DOSAGE AND ADMINISTRATION • RYBELSUS and OZEMPIC tablets are not substitutable on a mg-to-mg basis. • Take RYBELSUS or OZEMPIC tablets orally once daily on an empty stomach in the morning with water (up to 4 ounces of water); do not take with other liquids besides water. ( 2.1 ) • Swallow tablets whole. Do not split, crush, chew or dissolve in any solution. ( 2.1 ) • After taking RYBELSUS or OZEMPIC tablets, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications. ( 2.1 ) • See the Full Prescribing Information for instructions on switching between RYBELSUS and OZEMPIC tablets ( 2.3 ) and from OZEMPIC injections to RYBELSUS or OZEMPIC tablets. ( 2.4 ) Recommended Starting, Escalation and Maintenance Dosage of RYBELSUS and OZEMPIC Tablets ( 2.2 ) RY…

    Warnings

    5 WARNINGS AND PRECAUTIONS • Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including RYBELSUS or OZEMPIC tablets. Discontinue if pancreatitis is suspected. ( 5.2 ) • Diabetic Retinopathy Complications : Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored. ( 5.3 ) • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin : May increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin secretagogue or insulin may be necessary. ( 5.4 ) • Acute Kidney Injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.5 ) • Severe Gastro…

  • Ozempic
    (SEMAGLUTIDE) · A-S Medication Solutions
    Full label on DailyMed
    Indications & usage

    1 INDICATIONS AND USAGE OZEMPIC is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. Limitations of Use • OZEMPIC has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis [see Warnings and Precautions ( 5.2 )] . • OZEMPIC is not indicated for use in patients with type 1 diabetes mellitus. OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as: • an adjunct to diet and exercise to improve glycemic control…

    Dosage & administration

    2 DOSAGE AND ADMINISTRATION • Administer once weekly at any time of day, with or without meals ( 2.1 ). • Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly ( 2.2 ). • If additional glycemic control is needed, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose ( 2.2 ). • If additional glycemic control is needed, increase the dosage to 2 mg once weekly after at least 4 weeks on the 1 mg dosage ( 2.2 ). • If a dose is missed administer within 5 days of missed dose ( 2.2 ). • Inject subcutaneously in the abdomen, thigh, or upper arm ( 2.2 ). 2.1 Important Administration Instructions • Inspect OZEMPIC visually before use. It should appear clear and colorless. Do not use OZEMPIC if particulate matter and coloration is seen. • Ad…

    Warnings

    5 WARNINGS AND PRECAUTIONS • Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed ( 5.2 ). • Diabetic Retinopathy Complications: Has been reported in a clinical trial. Patients with a history of diabetic retinopathy should be monitored ( 5.3 ). • Never share an OZEMPIC pen between patients , even if the needle is changed ( 5.4 ). • Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary ( 5.5 ). • Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions ( 5.6 ). • Hypersensitivi…

  • Ozempic
    (SEMAGLUTIDE) · Novo Nordisk Pharmaceutical Industries, LP
    Full label on DailyMed
    Indications & usage

    1 INDICATIONS AND USAGE OZEMPIC is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. • to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) • to reduce the risk of major adverse cardiovascular events in adults with type…

    Dosage & administration

    2 DOSAGE AND ADMINISTRATION • Administer once weekly at any time of day, with or without meals. ( 2.1 ) • Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly. ( 2.2 ) • If additional glycemic control is needed, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose. ( 2.2 ) • If additional glycemic control is needed, increase the dosage to 2 mg once weekly after at least 4 weeks on the 1 mg dosage. ( 2.2 ) • To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dosage. ( 1 , 2.2 ) • If a dose is missed, administer within 5 days of missed dose. ( 2.1 ) • Inject subcutaneously in the abdomen, thigh, or upper arm.…

    Warnings

    5 WARNINGS AND PRECAUTIONS • Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including OZEMPIC. Discontinue if pancreatitis is suspected. ( 5.2 ) • Diabetic Retinopathy Complications: Has been reported in a clinical trial. Patients with a history of diabetic retinopathy should be monitored. ( 5.3 ) • Never share an OZEMPIC pen between patients , even if the needle is changed. ( 5.4 ) • Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary. ( 5.5 ) • Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.6 ) •…

Doses studied in research

Source: FDA-approved label

What published trials tested or FDA-approved labels specify. Reporting research facts — not a SmartPeptide recommendation.

FDA-approved labelWegovy / Ozempic FDA labels (DailyMed)
Indication studied: Chronic weight management (Wegovy) and type 2 diabetes (Ozempic)
Starting
250µg
once weekly · subcutaneous

Weeks 1-4 (Wegovy obesity)

Open calculator
Typical
1mg(1,000 µg)
once weekly · subcutaneous

Maintenance after titration

Open calculator
Maximum
2.4mg(2,400 µg)
once weekly · subcutaneous

Wegovy target dose for obesity

Open calculator

Notes from the source: Titration schedule: 0.25 → 0.5 → 1.0 → 1.7 → 2.4 mg, increasing every 4 weeks. Ozempic (T2D) tops out at 2.0 mg.

Important framing: The numbers above are what published trials tested or what FDA-approved labels specify. They are NOT a SmartPeptide recommendation for you. Trial doses come paired with screening, monitoring, and clinician oversight. Always consult a licensed clinician before any peptide use.

FDA enforcement & recalls

Live · openFDA Drug Enforcement API
Total actions
43
recalls + withdrawals
Ongoing
36
not yet completed
Class I (serious)
0
health hazard / death risk
  • Class IIOngoing· Voluntary: Firm initiated
    FDA record

    Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR

    Reason: Lack of Assurance of Sterility

    Mar 6, 2026·PAYLESS COMPOUNDERS, LLC
  • Class IIOngoing· Voluntary: Firm initiated
    FDA record

    Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06

    Reason: Lack of Assurance of Sterility

    Feb 26, 2026·New Life Pharma LLC
  • Class IIOngoing· Voluntary: Firm initiated
    FDA record

    Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.

    Reason: Lack of Assurance of Sterility

    Feb 26, 2026·New Life Pharma LLC
  • Class IIOngoing· Voluntary: Firm initiated
    FDA record

    Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 8438…

    Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

    Feb 13, 2026·Harbin Jixianglong Biotech Co., Ltd.
  • Class IIOngoing· Voluntary: Firm initiated
    FDA record

    Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbi…

    Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

    Feb 13, 2026·Harbin Jixianglong Biotech Co., Ltd.
Showing 8 of 43 total enforcement actions. See full FDA history →
FDA classifications: Class I = reasonable probability of serious adverse health consequences or death. Class II = temporary or medically reversible adverse consequences. Class III = unlikely to cause adverse health consequences.

Mechanism & targets

ChEMBL · UniProt · Open Targets

Molecule (ChEMBL)

View on ChEMBL
Formula
C187H291N45O59

Protein targets (UniProt)

  • Neprilysin
    P08473gene: MMEHomo sapiens· 750 aaReviewed

    Thermolysin-like specificity, but is almost confined on acting on polypeptides of up to 30 amino acids (PubMed:15283675, PubMed:6208535, PubMed:6349683, PubMed:8168535). Biologically important in the destruction of opioid peptides such as Met- and Leu-enkephalins by cleavage of a Gly-Phe bond (PubMed:17101991, PubMed:6349683). Catalyzes cleavage of bradykinin, substance P and neurotensin peptides (PubMed:6208535). Able to cleave angiotensin-1, angiotensin-2 and angiotensin 1-9 (PubMed:15283675,…

  • Glucagon-like peptide 1 receptor
    P43220gene: GLP1RHomo sapiens· 463 aaReviewed

    G protein-coupled receptor for glucagon-like peptide 1 (GLP-1) (PubMed:19861722, PubMed:26308095, PubMed:27196125, PubMed:28514449, PubMed:7517895, PubMed:8216285, PubMed:8405712). Ligand binding triggers activation of a signaling cascade that leads to the activation of adenylyl cyclase and increased intracellular cAMP levels (PubMed:19861722, PubMed:26308095, PubMed:27196125, PubMed:28514449, PubMed:7517895, PubMed:8216285, PubMed:8405712). Plays a role in regulating insulin secretion in respon…

  • Albumin
    P02768gene: ALBHomo sapiens· 609 aaReviewed

    Binds water, Ca(2+), Na(+), K(+), fatty acids, hormones, bilirubin and drugs (Probable). Its main function is the regulation of the colloidal osmotic pressure of blood (Probable). Major zinc transporter in plasma, typically binds about 80% of all plasma zinc (PubMed:19021548). Major calcium and magnesium transporter in plasma, binds approximately 45% of circulating calcium and magnesium in plasma (By similarity). Potentially has more than two calcium-binding sites and might additionally bind cal…

Live research

PubMed · ClinicalTrials.gov · Europe PMC · OpenAlex
PubMed papers
5,205
total
Human studies
0
MeSH: humans
Clinical trials
0
published
Active trials
173
739 total registered

Clinical trials (ClinicalTrials.gov)

All trials for "semaglutide"

Europe PMC — 15,699 additional records

Includes EU/UK studies and PubMed Central full-text articles. Often surfaces research weeks before PubMed indexes it.

Research volume (OpenAlex topic graph)

Total works
29,781
all years
Last 5 years
27,175
recent activity
Open access
24,074
freely readable
OA share
81%
of all works

Human clinical evidence

Semantic Scholar · AI TLDRs · influence-ranked
Semantic Scholar API is currently rate-limited.

Human-study summaries for “semaglutide” are available on Semantic Scholar but the shared free-tier API quota is exhausted right now. Try refreshing in a few minutes, or check the PubMed and Europe PMC panels above for the same literature.

Research funding & verification

NIH RePORTER · CrossRef DOI registry

NIH-funded research

U.S. National Institutes of Health
Funded projects
181
all years
Top award sum
$57.7M
aggregate USD
Years covered
8
research span
Largest active / recent grants

Publication landscape

CrossRef · DOI registry
Indexed works (CrossRef)
6,618
all DOIs registered
Retracted papers
0
no retractions on record
Top funders of indexed research
  • Novo Nordisk202 works
  • Novo Nordisk A/S94 works
  • National Natural Science Foundation of China55 works
  • Eli Lilly and Company36 works
  • National Institutes of Health34 works
  • National Institute of Diabetes and Digestive and Kidney Diseases18 works

Funder diversity is a credibility signal. Research concentrated in a single drug company's funding warrants more scrutiny than research funded across NIH, charities, and academic grants.

Preprints — cutting edge

bioRxiv · medRxiv · via Europe PMC

Preprints have NOT been peer-reviewed. They are early research shared by authors before formal validation. Treat findings as preliminary.

Showing 6 of 354 preprints indexed by Europe PMC.

Known risks

Pancreatitis risk, gallbladder events, contraindicated in personal/family history of medullary thyroid carcinoma.

Reported side effects

Nausea, GI upset, constipation, fatigue. Discuss with a licensed prescriber.

FDA adverse event reports (FAERS)

Updated quarterly by FDA
Reports filed
83,486
FAERS, all years
Serious reports
44,799
54% of reports
Top reporting countries
  • US62,064
  • CA3,749
  • GB2,819
  • EU1,554

Most-reported reactions

  • Nausea
    12,264
  • Vomiting
    8,171
  • Off Label Use
    7,322
  • Diarrhoea
    7,041
  • Constipation
    4,996
  • Decreased Appetite
    4,989
  • Weight Decreased
    4,366
  • Fatigue
    3,767
  • Headache
    3,587
  • Product Use In Unapproved Indication
    3,188

Counts from FDA Adverse Event Reporting System (FAERS). Voluntary reports — they show what was reported, not whether the drug caused the event. Many reports lack confirmation. FAERS docs

What requires medical supervision

Prescription medication. Contraindicated in personal/family history of medullary thyroid carcinoma or MEN-2. Pancreatitis and gallbladder events are documented risks. Requires baseline and follow-up clinical assessment.

Questions for your clinician

  • Am I a candidate based on BMI, comorbidities, and contraindications?
  • What labs should we monitor (lipase, HbA1c, thyroid function)?
  • What's the plan if GI side effects become severe?
  • How do we approach maintenance after target weight is reached?

Editorially curated references

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