A Phase 1 interventional study of Semaglutide 0.5 mg and Placebo (semaglutide 0.5 mg) in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-15.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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Among 163 studies testing semaglutide in Diabetes Mellitus, Type 2 — 35 open to participants now, 45 under way, 9 of them phase 3. Semaglutide · Diabetes Mellitus, Type 2.
Among the 163 studies testing semaglutide in Diabetes Mellitus, Type 2, this one is the 140th largest by enrollment, is one of 9 that started in 2017, is one of 41 in phase 1, and was the 46th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →35 of the 163 studies testing semaglutide in Diabetes Mellitus, Type 2 are open now, in 12 countries. Recruiting first, the newest first:
Mapi Pharma Ltd. · Sites in Israel
Ages 18–64
Emory University · Sites in United States
Ages 65+ · Women only
Daewoong Pharmaceutical Co. LTD. · Sites in Korea, Republic of
Ages 19–64 · Healthy volunteers
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 18–70
Ottawa Heart Institute Research Corporation · Sites in Canada
Ages 18+
By country, each count listing its studies:
Semaglutide: first FDA approval 2017 (OZEMPIC), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, semaglutide is the treatment under test here. Read study by study →
163 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 14 · Phase 3 58 · Phase 4 40
First in 2007; this study’s year is marked. 9 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 104 across the 163 interventional studies. Of the 109 that completed or were terminated, 54 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
100 of 163 have an industry lead sponsor. The 10 most frequent:
Novo Nordisk A/S is the lead sponsor of 1,408 studies on the registry; 105 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
643 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S: 25 open now, 29 under way, 11 of them phase 3. Of 603 finished, 174 (29%) have results posted.
Among the 643 studies in Diabetes Mellitus, Type 2 by Novo Nordisk A/S, this one is the 358th largest by enrollment of the 428 interventional ones that give a count, is one of 17 that started in 2017, is one of 129 in phase 1, and was the 442nd registered.
Novo Nordisk A/S’s Diabetes Mellitus, Type 2 studies by the year they started, since 1997.
14 of the studies testing semaglutide in Diabetes Mellitus, Type 2 that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07059377Phase 3Ottawa Heart Institute Research CorporationSemaglutide for Smoking Cessation in Patients With Diabetes | 2026-12 |
| NCT03811561Phase 3Novo Nordisk A/SA Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | 2027-11-07 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
| NCT06715514Lia BallyMenopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Overweight/Obesity and Impaired Glucose Homeostasis | 2026-12-17 |
| NCT06461377The First Affiliated Hospital with Nanjing Medical UniversityThe Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy | 2026-12-31 |
Add all 14 to your calendar (.ics) → With an account.
Among the 163 studies testing semaglutide in Diabetes Mellitus, Type 2, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Novo Nordisk A/S’s 643 in Diabetes Mellitus, Type 2:
This tab as a report to print or save as PDF → With an account.
The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way the drug is distributed in the body over a period of time) following once-weekly administration of semaglutide in healthy Chinese subjects. Different dose levels (0.5 and 1.0 mg) will be investigated in this trial. Participants will be administered semaglutide or placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall) using a pen injector with a very small, thin needle by the trial doctor at the trial site for 13 weeks. The trial consists of 23 visits in total, including visit for screening and safety tests, visit for dose administration and blood sample collection. The total time of participation will be approximately 18-22 weeks depending on participant's individual visit schedule.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Novo Nordisk A/S is the lead sponsor of 1,408 studies on the registry; 105 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
Compared within Diabetes Mellitus, Type 2, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will enter a 13 weeks treatment with 4 weeks dosing at dose level 0.25 mg and 9 weeks at 0.5 mg semaglutide.
Drug: Semaglutide 0.5 mg
Participants will enter a 13 weeks treatment with 4 weeks dosing at dose level 0.25 mg and 9 weeks at 0.5 mg semaglutide placebo.
Drug: Placebo (semaglutide 0.5 mg)
Participants will have 13 weeks treatment with 4 weeks dosing at dose level of 0.25 mg, 4 weeks at 0.5 mg, and 5 weeks at 1.0 mg semaglutide.
Drug: Semaglutide 1.0 mg
Participants will have 13 weeks treatment with 4 weeks dosing at dose level of 0.25 mg, 4 weeks at 0.5 mg, and 5 weeks at 1.0 mg semaglutide placebo.
Drug: Placebo (semaglutide 1.0 mg)
A dose of 0.25 mg semaglutide gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
A dose of 0.25 mg semaglutide placebo gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
A dose of 0.25 mg semaglutide gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
A dose of 0.25 mg semaglutide placebo gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 0.5 mg)
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Area under the semaglutide plasma concentration time curve at steady state (semaglutide 1.0 mg)
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Maximum observed semaglutide plasma concentration at steady state
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Time to maximum observed semaglutide plasma concentration at steady state
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Total apparent clearance of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after last administration of semaglutide
Terminal elimination half-life of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Time frame: 0-840 hours after last administration of semaglutide
Apparent volume of distribution of semaglutide at steady state
Calculated based on semaglutide measured in blood.
Time frame: 0-840 hours after last administration of semaglutide
Trough plasma semaglutide concentration
Calculated based on semaglutide measured in blood.
Time frame: Before dosing at day 29, 57, 78, 85 and 92
Dose-corrected accumulation ratio
Calculated based on semaglutide measured in blood.
Time frame: Based on the area under the semaglutide plasma concentration curve from 0-168 hours after the first dose and the area under the semaglutide plasma concentration curve 0-168 hours after the last dose
Area under the semaglutide plasma concentration time curve
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Maximum observed semaglutide plasma concentration
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Time to maximum observed semaglutide plasma concentration
Calculated based on semaglutide measured in blood.
Time frame: 0-168 hours after the first dose of semaglutide 0.25 mg (starting dose level)
Number of treatment emergent adverse events (TEAEs)
Count and % of adverse events
Time frame: Visit 2 (Day 1) - visit 23 (Day 120-127)
Number of hypoglycaemic episodes
Count of episodes
Time frame: Visit 2 (Day 1) - visit 23 (Day 120-127)
Incidence of anti-semaglutide antibodies (positive/negative) at follow-up
Count of episodes
Time frame: Visit 23 (Day 120-127)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Ran from Sep 2017 to primary completion in Jul 2018, 9 months.
Of 453 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 9 months is above that.
Counting every sponsor, half of 515 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide