2020

Kirsi Pietiläinen, University of Helsinki

Haartmaninkatu 8, Helsinki, Finland, 00290

Lihavuustutkimusyksikkö, Obesity Research Unit / Lihavuustutkimusyksikkö, lihavuustutkimusyksikko@gmail.com

Lihavuustutkimusyksikkö, Obesity Research Unit / Lihavuustutkimusyksikkö, +358 505992295, lihavuustutkimusyksikko@gmail.com

No

No

No

Final

23 Mar 2026

Yes

18 Dec 2024

Yes

18 Dec 2024

No

The primary objective of this study was to investigate the effect of subcutaneous 1mg once weekly semaglutide treatment compared with placebo treatment on glucose homeostasis (HbA1c) in patients with T2DM following diet-induced weight loss intervention at 12 months.

The safety and tolerability of the study procedures were assessed throughout the trial, for example by monitoring adverse events, laboratory parameters, vital signs, and findings from physical examinations. Any adverse effects were treated as needed during the study. Participants in both groups could experience discomfort or adverse effects related to injections, tissue sampling, and laboratory tests. However, all procedures employed have been routinely performed at our study site for several years, and the experienced study staff consistently prioritised safety and reliability. The weight-loss intervention could also cause discomfort, such as constipation, headache, and fatigue. The intervention was implemented with particular care to minimise the risk of muscle loss or micronutrient deficiencies, and nutritional status was evaluated and counselling provided at each study visit by a registered dietitian. To ensure participant safety and to prevent misunderstandings regarding any aspect of the study procedures, only Finnish-speaking participants were recruited, in accordance with the study protocol. In the event of an emergency, the study blind could be broken at the investigator’s discretion.

01 Apr 2021

No

No

Finland: 20

20

20

0

0

0

0

0

0

20

0

0

Overall trial (overall period)

Randomised - controlled

At the 8-week time point after the low calorie diet phase, the patients were randomized in a 1:1 manner to either semaglutide or placebo. The randomization was done so that semaglutide and placebo groups had similar shares of sexes and similar mean age, and BMI. The study blind could have been broken in a case of emergency by the judgement of the investigator, but there was no need for that.

Yes

semaglutide

Ozempic®

Suspension for injection in pre-filled injector

Subcutaneous use

The investigational product used in the trial was semaglutide 1 mg/week or placebo, formulated as a solution for subcutaneous injection in a pre-filled pen injector. Semaglutide and placebo were visually identical and packaged in a blinded manner to maintain double-blind treatment conditions. All participants were instructed on how to self-administer the weekly injections. Dose escalation was carried out in two titration steps, beginning with 0.25 mg once weekly for 4 weeks, followed by 0.5 mg once weekly for a further 4 weeks, after which 1.0 mg was administered once weekly until the end of the 12-month study period.

semaglutide

Ozempic

Solution for injection in pre-filled pen

Subcutaneous use

The subjects self-administered semaglutide (1.34 mg/mL) or placebo once weekly at home after receiving training on the correct subcutaneous injection technique. Dosing was escalated from 0.25 mg once weekly for 4 weeks to 0.5 mg once weekly for 4 weeks, followed by 1.0 mg once weekly until the end of the 12-month study.

Placebo

Solution for injection in pre-filled pen

Subcutaneous use

The subjects self-administered semaglutide (1.34 mg/mL) or placebo once weekly at home after receiving training on the correct subcutaneous injection technique. Dosing was escalated from 0.25 mg once weekly for 4 weeks to 0.5 mg once weekly for 4 weeks, followed by 1.0 mg once weekly until the end of the 12-month study.

Semaglutide

Placebo

Semaglutide

Placebo

Primary

From baseline to 12 months

We estimated treatment effects at each timepoint using linear mixed effects model (R package lme4). Models included mean-centered baseline values as a fixed-effect covariate, and participant ID as a random-effect covariate. For each outcome, we used an interaction model to evaluate the effect of the semaglutide treatment, i.e. the estimated treatment difference.

Semaglutide v Placebo

20

Pre-specified

-4.8

2-sided

Secondary

From baseline to 12 months

We estimated treatment effects at each timepoint using linear mixed effects model (R package lme4). Models included mean-centered baseline values as a fixed-effect covariate, and participant ID as a random-effect covariate. For each outcome, we used an interaction model to evaluate the effect of the semaglutide treatment, i.e. the estimated treatment difference.

Semaglutide v Placebo

20

Pre-specified

-8.2

2-sided

We recruited the first participant on February 16, 2022, and the last study visit conducted on December 18, 2024 and between these time point all adverse events were reported.

Adverse events were reported in both treatment groups and were predominantly mild to moderate in severity. The types of events observed were broadly similar between groups.

28

Semaglutide

Placebo