High-Dose Semaglutide (Up to 16 mg) in People With Type 2 Diabetes and Overweight or Obesity: A Randomized, Placebo-Controlled, Phase 2 Trial.

Aroda VR, Jørgensen NB, Kumar B, Lingvay I, Laulund AS, Buse JB

Diabetes care1 Jun 2025Cited by 18 (Europe PMC)

PMID40279144PMCIDPMC12094194DOI10.2337/dc24-2425PepBankPUB-40279144

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and overweight or obesity on metformin, semaglutide 16 mg did not lower HbA1c significantly more than 2 mg under the treatment policy estimand (difference -0.3 percentage points; P = 0.245).
In plain wordsIn adults with type 2 diabetes and overweight, semaglutide 16 mg did not clearly lower HbA1c more than 2 mg in the main analysis.
Peptide
Semaglutide
Outcome
No significant changeHbA1c change, 16 mg vs 2 mg (treatment policy estimand)
Study
n: not reported in source
Comparator
Semaglutide 2 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
16 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Estimated treatment difference in HbA1c
−0.3 %-points
16 vs 2 mg, treatment policy
Source sentences
Summary
Estimated treatment difference between 16 and 2 mg was -0.3 percentage points (%-points) (95% CI -0.7 to 0.2; P = 0.245) for HbA1c change and -3.4 kg (-6.0 to -0.8; P = 0.011) for weight change for the treatment policy estimand and -0.5%-points (-1.0 to -0.1; P = 0.015) and -4.5 kg (-7.6 to -1.4; P…
1 context sentence(design, population, supporting numbers)
Summary · context
In this parallel-group, participant- and investigator-blinded, phase 2 trial, 245 individuals with type 2 diabetes and BMI ≥27 kg/m2 on metformin were randomized to weekly semaglutide (2, 8, or 16 mg s.c.) or placebo for 40 weeks.
Report a problemFND-4027914401
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and overweight or obesity on metformin, semaglutide 16 mg lowered HbA1c more than 2 mg under the hypothetical estimand (difference -0.5 percentage points; P = 0.015).
In plain wordsIn adults with type 2 diabetes and overweight, semaglutide 16 mg lowered HbA1c more than 2 mg when treatment was assumed to continue.
Peptide
Semaglutide
Outcome
DecreaseHbA1c change, 16 mg vs 2 mg (hypothetical estimand)
Study
n: not reported in source
Comparator
Semaglutide 2 mg
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
16 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Estimated treatment difference in HbA1c
−0.5 %-points
16 vs 2 mg, hypothetical
Source sentences
Summary
Estimated treatment difference between 16 and 2 mg was -0.3 percentage points (%-points) (95% CI -0.7 to 0.2; P = 0.245) for HbA1c change and -3.4 kg (-6.0 to -0.8; P = 0.011) for weight change for the treatment policy estimand and -0.5%-points (-1.0 to -0.1; P = 0.015) and -4.5 kg (-7.6 to -1.4; P…
1 context sentence(design, population, supporting numbers)
Summary · context
In this parallel-group, participant- and investigator-blinded, phase 2 trial, 245 individuals with type 2 diabetes and BMI ≥27 kg/m2 on metformin were randomized to weekly semaglutide (2, 8, or 16 mg s.c.) or placebo for 40 weeks.
Report a problemFND-4027914402
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and overweight or obesity on metformin, semaglutide 16 mg reduced body weight more than 2 mg under the treatment policy estimand (difference -3.4 kg; P = 0.011).
In plain wordsIn adults with type 2 diabetes and overweight, semaglutide 16 mg led to 3.4 kg more weight loss than 2 mg in the main analysis.
Peptide
Semaglutide
Outcome
DecreaseBody weight change, 16 mg vs 2 mg (treatment policy estimand)
Study
n: not reported in source
Comparator
Semaglutide 2 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
16 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Estimated treatment difference in body weight
−3.4 kg
16 vs 2 mg, treatment policy
Source sentences
Summary
Estimated treatment difference between 16 and 2 mg was -0.3 percentage points (%-points) (95% CI -0.7 to 0.2; P = 0.245) for HbA1c change and -3.4 kg (-6.0 to -0.8; P = 0.011) for weight change for the treatment policy estimand and -0.5%-points (-1.0 to -0.1; P = 0.015) and -4.5 kg (-7.6 to -1.4; P…
1 context sentence(design, population, supporting numbers)
Summary · context
In this parallel-group, participant- and investigator-blinded, phase 2 trial, 245 individuals with type 2 diabetes and BMI ≥27 kg/m2 on metformin were randomized to weekly semaglutide (2, 8, or 16 mg s.c.) or placebo for 40 weeks.
Report a problemFND-4027914403
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and overweight or obesity on metformin, semaglutide 16 mg reduced body weight more than 2 mg under the hypothetical estimand (difference -4.5 kg; P = 0.004).
In plain wordsIn adults with type 2 diabetes and overweight, semaglutide 16 mg gave 4.5 kg more weight loss than 2 mg if treatment continued.
Peptide
Semaglutide
Outcome
DecreaseBody weight change, 16 mg vs 2 mg (hypothetical estimand)
Study
n: not reported in source
Comparator
Semaglutide 2 mg
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
16 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Measurements
Estimated treatment difference in body weight
−4.5 kg
16 vs 2 mg, hypothetical
Source sentences
Summary
Estimated treatment difference between 16 and 2 mg was -0.3 percentage points (%-points) (95% CI -0.7 to 0.2; P = 0.245) for HbA1c change and -3.4 kg (-6.0 to -0.8; P = 0.011) for weight change for the treatment policy estimand and -0.5%-points (-1.0 to -0.1; P = 0.015) and -4.5 kg (-7.6 to -1.4; P…
1 context sentence(design, population, supporting numbers)
Summary · context
In this parallel-group, participant- and investigator-blinded, phase 2 trial, 245 individuals with type 2 diabetes and BMI ≥27 kg/m2 on metformin were randomized to weekly semaglutide (2, 8, or 16 mg s.c.) or placebo for 40 weeks.
Report a problemFND-4027914404
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and overweight or obesity, no severe hypoglycemic episodes were reported with semaglutide.
In plain wordsIn adults with type 2 diabetes and overweight, no severe low blood sugar episodes were reported with semaglutide.
Peptide
Semaglutide
Outcome
No significant changeSevere hypoglycemic episodes
Study
n = 245
Outcome group
Adverse events · Metabolic and weight
Studied dose
2, 8 and 16 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Source sentences
Summary
No severe hypoglycemic episodes were reported.
1 context sentence(design, population, supporting numbers)
Summary · context
In this parallel-group, participant- and investigator-blinded, phase 2 trial, 245 individuals with type 2 diabetes and BMI ≥27 kg/m2 on metformin were randomized to weekly semaglutide (2, 8, or 16 mg s.c.) or placebo for 40 weeks.
Report a problemFND-4027914407
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and overweight or obesity, treatment-emergent adverse events, primarily gastrointestinal, were more frequent with semaglutide 8 and 16 mg than with 2 mg.
In plain wordsIn adults with type 2 diabetes and overweight, semaglutide 8 and 16 mg caused more side effects, mostly gut-related, than 2 mg.
Peptide
Semaglutide
Outcome
IncreaseTreatment-emergent adverse events
Study
n: not reported in source
Comparator
Semaglutide 2 mg
Outcome group
Adverse events · Whole body
Studied dose
8 and 16 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Source sentences
Summary
Treatment-emergent adverse events (AEs) and treatment discontinuations due to AEs, primarily gastrointestinal, were more frequent in the semaglutide 8 and 16 mg groups than in the 2 mg group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this parallel-group, participant- and investigator-blinded, phase 2 trial, 245 individuals with type 2 diabetes and BMI ≥27 kg/m2 on metformin were randomized to weekly semaglutide (2, 8, or 16 mg s.c.) or placebo for 40 weeks.
Report a problemFND-4027914405
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and overweight or obesity, discontinuations due to adverse events, primarily gastrointestinal, were more frequent with semaglutide 8 and 16 mg than with 2 mg.
In plain wordsIn adults with type 2 diabetes and overweight, more people stopped semaglutide 8 and 16 mg because of side effects than 2 mg.
Peptide
Semaglutide
Outcome
IncreaseTreatment discontinuations due to adverse events
Study
n: not reported in source
Comparator
Semaglutide 2 mg
Outcome group
Adverse events · Whole body
Studied dose
8 and 16 mg weekly · subcutaneous · 40 weeksAs given in this study (human).
Source sentences
Summary
Treatment-emergent adverse events (AEs) and treatment discontinuations due to AEs, primarily gastrointestinal, were more frequent in the semaglutide 8 and 16 mg groups than in the 2 mg group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this parallel-group, participant- and investigator-blinded, phase 2 trial, 245 individuals with type 2 diabetes and BMI ≥27 kg/m2 on metformin were randomized to weekly semaglutide (2, 8, or 16 mg s.c.) or placebo for 40 weeks.
Report a problemFND-4027914406

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:04 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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