ClinicalTrials.gg
Active, not recruitingNCT07421024GAINUpdated Oct 14, 2026

GRK-Biased Activation Via β2-Adrenergic Receptors in Human Skeletal Muscle

A Phase 2 interventional study of ATR-258 in Overweight and Obesity, sponsored by Morten Hostrup, PhD. Active, not recruiting at 1 site in Denmark. Open to male participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Morten Hostrup, PhD · Phase 2, Interventional, and Basic science

Updated Oct 14, 2026Enrollment updatedPrimary outcomes revised+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
21 Years to 45 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 350 studies in Obesity with a site in Denmark — 58 open to participants now, 84 under way, 23 of them phase 3. Obesity · Denmark.

Enrollment
263rd of 282
13 · median 74
Started
2026
with 25 others
Phase 2
20 of 350
2 open now
Primary completion
2026-12
later than 35 of 83 live
Registered
328th of 350
by date

Among the 350 studies in Obesity with a site in Denmark, this one is the 263rd largest by enrollment of the 282 interventional ones that give a count, is one of 26 that started in 2026, is one of 20 in phase 2, reaches primary completion later than 35 of the 83 other live ones, and was the 328th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

58 of the 350 studies in Obesity with a site in Denmark are open now. Recruiting first, the newest first:

53 more — sign in →

All 58 open studies →

A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 21 Years to 45 Years · male · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 350 studies in Obesity with a site in Denmark, or all of them as a file.
02

Study summary

This longitudinal mechanistic physiological study examines biased β2-adrenergic receptor (β2-AR) signaling in human skeletal muscle, with emphasis on G protein-coupled receptor kinase (GRK)-mediated pathways. Participants will receive daily oral dosing of the GRK-selective long-acting β2-agonist ATR-258 for 8 weeks. Muscle biopsies and physiological measurements will quantify GRK-, cAMP/PKA-, and β-arrestin-related up- and downstream signaling, fiber-type specificity, and potential receptor desensitization with repeated stimulation along with functional read-outs, tissue distribution, cardiovascular response and tolerability.

Read the detailed description

Healthy men with overweight/obesity will complete an 8-week intervention with daily oral ATR-258 (0.5-2.5 mg/day). On experimental days (Days 1, 15, 29, and 56), β2-AR signaling sensitivity will be assessed before and after stimulation (1-2, 4, and 8 hours) using blood biomarkers, hemodynamics, indirect calorimetry, and lower extremity muscle function/power testing. Muscle biopsies (vastus lateralis) will be obtained at rest and 4 hours after stimulation on Days 1, 29, and 56 to quantify downstream signaling (GRK, cAMP/PKA, β-arrestin), phosphorylation of rpS6/mTOR/Akt, β2-AR content, and muscle fiber morphology.

03

Conditions studied

  • Overweight and Obesity

Browse trials for

Keywords

  • beta2
  • muscle
  • atr-258
  • adrenergic
  • biased signaling
04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 13 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Morten Hostrup, PhD is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Healthy men
  • Age 21-45 years
  • 25-35 kg/m\^2
  • Body fat percentage 25-40%
  • Lean Mass Index 14-22

Exclusion criteria

Exclusion Criteria:

  • Regular use of or allergy to β2-agonists
  • Serious adverse reactions to β2-agonists
  • Current smoker
  • Regular use of medication (except OTC allergy or analgesics)
  • Abnormal before or after β2-AR stimulation
  • Hypertension
  • Reduced kidney function ( \< 90 ml/min/1.73m\^2)
  • Cardiovascular, metabolic, gastrointestinal, renal, or pulmonary disease
  • Psychiatric or neurological disorders affecting compliance/safety reporting
  • Cancer history within the last 5 years
  • Substance abuse or alcohol intake >14 units/week
Terms in these criteria, in plain language(3)

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.

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

06

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    ATR-258

    Daily oral ATR-258

    Drug: ATR-258

Interventions

  • Daily oral ATR-258 for 8 weeks with repeated experimental assessment days (Days 1, 15, 29, 56).

07

What researchers measure

Primary outcomes

  1. Intensity of β2-AR downstream signaling pathways (e.g. GRK, cAMP/PKA, β-arrestin, rpS6) in type I and type II muscle fibers

    Assessed in vastus lateralis biopsies at rest

    Time frame: Before and 4 hours after ATR-258 ingestion on day 1, 29, and 56.

Secondary outcomes

  1. Phosphorylation of rpS6, mTOR, and Akt in type I and type II muscle fibers

    In response to ATR-258 ingestion

    Time frame: Day 1, 29 and, 56.

  2. Lean/fat mass

    Measured by DXA scan

    Time frame: Day 1, 15, 29, and 56

  3. Muscle function

    Participants will perform lower extremity peak exercise and a one-legged knee-extensor exercise protocol to exhaustion before and after the full intervention to assess muscle power and endurance

    Time frame: Pre and post 8 weeks of daily ATR-258 ingestion. Post visit conducted 2-5 days after last day of ATR-258 ingestion.

  4. Peripheral glucose clearance including OGTT-derived outcomes

    Time frame: Pre and post 8 weeks of daily ATR-258 ingestion. Post visit conducted 2-5 days after last day of ATR-258 ingestion.

  5. β2-adrenergic receptor content in type I and type II muscle fibers

    Measured by western blotting

    Time frame: On day 1, 29 and 56

  6. Resting metabolic rate (incl. carbohydrate and fat oxidation)

    Measured by indirect calorimetry

    Time frame: Before and 1, 2, 4 and 8 hours after ATR-258 ingestion on day 1, 15, 29, and 56.

  7. Femoral arterial blood flow

    Measured by Doppler.

    Time frame: Before and 1, 2, 4 and 8 hours after ATR-258 ingestion on day 1, 15, 29, and 56.

  8. Continous ECG and heart rate

    Participants will wear a Holter-device for 4 x 5 days to continuously measure ECG and heart rate. The periods will be after the screening (baseline period), and after trial days on Day 1, 15, and 29.

    Time frame: A 5-day baseline period, and day 1-5, day 15-20, and day 29-34 of ATR-258 administration.

  9. Muscle fiber cross-sectional area (type I and type II)

    Measured by histochemical analysis

    Time frame: Day 1, 29, and 56

  10. Maximal electrically-stimulated muscle force development and relaxation

    Isometric quadriceps. Measured seated with leg in 90 degree angle and attached to strain gauge.

    Time frame: Pre and post 8 weeks of daily ATR-258 ingestion. Post visit conducted 2-5 days after last day of ATR-258 ingestion.

08

Study locations

1 site
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.

Of 132 non-industry phase 2 interventional studies under Obesity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 57. This study's planned 10 months is below that.

Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2026
First posted
Feb 19, 2026
StartActual
Feb 19, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary outcomes
1 edited
What changed in the outcomes
  • EditedIntensity of β2-AR downstream signaling pathways (e.g. GRK, cAMP/PKA, and β-arrestin, rpS6) in type I and type II muscle fibersTime frame: Before and 4 hours after ATR-258 ingestion on day 1, 29, and 56.
Oct 14, 2026
Title
GRK-Biased GRK SignalingActivation Via β2-Adrenergic Receptors in Human Skeletal Muscle
Oct 14, 2026
Sponsor
Collaborators added: Bispebjerg Hospital
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedIntensity of β2-AR downstream signaling pathways (e.g. GRK, cAMP/PKA, and β-arrestin, rpS6) in type I and type II muscle fibersTime frame: Before and 4 hours after ATR-258 ingestion on day 1, 29, and 56.
    Sponsor Collaborators added: Bispebjerg Hospital
    Title GRK-Biased GRK SignalingActivation Via β2-Adrenergic Receptors in Human Skeletal Muscle
    + 2 other changes: verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT07421024
Lead sponsor
Morten Hostrup, PhD
Collaborators
Atrogi AB, University of Copenhagen, Stockholm University, Bispebjerg Hospital
Responsible party
Morten Hostrup, PhD (Senior Researcher, Professor, MD, University of Copenhagen) — Sponsor-investigator
First posted
Feb 19, 2026
Start date
Feb 19, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: ATR-258

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